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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| National Evaluation System for health Technology Coordinating Center | OTHER |
| Pear Therapeutics, Inc. | INDUSTRY |
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This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks
This is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia (i.e., Somryst, herein called PEAR-003b) using a novel patient-centered data sharing platform (called Hugo), with linkage to Fitbit (Inspire 2), among 100 patients with chronic insomnia. Half of the patients with insomnia will receive the PEAR-003b digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the PDT but will receive a Fitbit and be enrolled in the Hugo platform. The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up. All patients will be evaluated at baseline, as well as prompted to complete additional assessments at weeks 9, 21, 35, and 61. The PEAR-003b intervention will deliver CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Additionally, the Hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes. These real-world data points and trends collected as part of this pilot investigation will help inform a future larger healthcare effectiveness and outcomes research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAR-003b PDT Intervention | Experimental | Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. |
|
| Control Arm | Placebo Comparator | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAR-003b PDT Intervention | Device | The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | From baseline to 9 weeks post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) |
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Inclusion Criteria:
• Age between 22-64 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph S Ross, MD MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940841 | Derived | Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Aug 8;12(8):e062041. doi: 10.1136/bmjopen-2022-062041. |
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Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes. The exact plan has yet to be decided.
Data will become available once the study has been completed
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| ID | Title | Description |
|---|---|---|
| FG000 | PEAR-003b PDT Intervention | Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
| FG001 | Control Arm | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Participant Flow number differs from the Overall Number of Baseline Participants because two enrolled participants did not complete their baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | PEAR-003b PDT Intervention | Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 enrolled participant did not answer this survey question |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | Primary outcome measure was erased from study surveys and therefore not collected. | Posted | From baseline to 9 weeks post randomization |
|
up to 61 weeks post-randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEAR-003b PDT Intervention | Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Ross, MD, MHS | Yale University | 203-785-2987 | joseph.ross@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2021 | Feb 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2022 | Feb 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Fitbit | Device | Patients will receive a Fitbit and receive standard of care |
|
| Sleep education materials | Behavioral | Patients will receive sleep hygiene and healthy sleep tips. |
|
| From baseline to 21 weeks post-randomization |
| Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | From baseline to 35 weeks post-randomization |
| Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | From baseline to 61 weeks post-randomization |
| Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 9 weeks post-randomization |
| Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 21 weeks post-randomization |
| Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 35 weeks post-randomization |
| Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 61 weeks post-randomization |
| Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | From baseline to 9 weeks post-randomization |
| Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | From baseline to 21 weeks post-randomization |
| Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | From baseline to 35 weeks post-randomization |
| Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | From baseline to 61 weeks post-randomization |
| Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | From baseline to 9 weeks post-randomization |
| Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | From baseline to 21 weeks post-randomization |
| Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | From baseline to 35 weeks post-randomization |
| Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | From baseline to 61 weeks post-randomization |
| Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | From baseline to 9 weeks post-randomization |
| Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | From baseline to 21 weeks post-randomization |
| Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | From baseline to 35 weeks post-randomization |
| Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | From baseline to 61 weeks post-randomization |
| Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 9 weeks post-randomization |
| Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 21 weeks post-randomization |
| Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 35 weeks post-randomization |
| Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | From baseline to 61 weeks post-randomization |
| Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | From baseline to 9 weeks post-randomization |
| Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | From baseline to 21 weeks post-randomization |
| Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | From baseline to 35 weeks post-randomization |
| Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | From baseline to 61 weeks post-randomization |
| Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | From baseline to 9 weeks post-randomization |
| Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | From baseline to 21 weeks post-randomization |
| Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | From baseline to 35 weeks post-randomization |
| Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | From baseline to 61 weeks post-randomization |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | From baseline to 9 weeks post-randomization |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | From baseline to 21 weeks post-randomization |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | From baseline to 35 weeks post-randomization |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | From baseline to 61 weeks post-randomization |
| Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | From baseline to 9 weeks post-randomization |
| Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | From baseline to 21 weeks post-randomization |
| Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | From baseline to 35 weeks post-randomization |
| Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | From baseline to 61 weeks post-randomization |
| Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 9 weeks post-randomization. | From baseline to 9 weeks post-randomization |
| Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 21 weeks post-randomization. | From baseline to 21 weeks post-randomization |
| Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 35 weeks post-randomization. | From baseline to 35 weeks post-randomization |
| Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 61 weeks post-randomization. | From baseline to 61 weeks post-randomization |
| Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | From baseline to 9 weeks post-randomization |
| Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | From baseline to 21 weeks post-randomization |
| Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | From baseline to 35 weeks post-randomization |
| Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | From baseline to 61 weeks post-randomization |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG001 | Control Arm | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control Arm | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. |
|
| Secondary | Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated. | Posted | From baseline to 21 weeks post-randomization |
|
|
| Secondary | Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated. | Posted | From baseline to 35 weeks post-randomization |
|
|
| Secondary | Change in Insomnia Severity | Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated. | Posted | From baseline to 61 weeks post-randomization |
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 9 weeks post-randomization |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
|
|
|
| Secondary | Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 9 weeks post-randomization |
|
|
|
| Secondary | Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
|
|
|
| Secondary | Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
|
|
|
| Secondary | Change in Anxiety | The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
|
|
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| Secondary | Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Stress | The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Quality of Life (PCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Daytime Sleepiness | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
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| Secondary | Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 9 weeks post-randomization |
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| Secondary | Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 21 weeks post-randomization |
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| Secondary | Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 35 weeks post-randomization |
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| Secondary | Healthcare Utilization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 61 weeks post-randomization |
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| Secondary | Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 9 weeks post-randomization |
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| Secondary | Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 21 weeks post-randomization |
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| Secondary | Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 35 weeks post-randomization |
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| Secondary | Medication Utilization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. | The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded. | Posted | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | Posted | Mean | Standard Deviation | percentage points | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | Posted | Mean | Standard Deviation | percentage points | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | Posted | Mean | Standard Deviation | percentage points | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points) | Posted | Mean | Standard Deviation | percentage points | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | Posted | Mean | Standard Deviation | hours | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | Posted | Mean | Standard Deviation | hours | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | Posted | Mean | Standard Deviation | hours | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Sleep Onset Latency | Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep. | Posted | Mean | Standard Deviation | hours | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 9 weeks post-randomization. | Posted | Mean | Standard Error | percent change | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 21 weeks post-randomization. | Posted | Mean | Standard Error | percentage change | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 35 weeks post-randomization. | Posted | Mean | Standard Error | percentage change | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Health Utility Score | The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 61 weeks post-randomization. | Posted | Mean | Standard Error | percentage change | From baseline to 61 weeks post-randomization |
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| Secondary | Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 9 weeks post-randomization |
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| Secondary | Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 21 weeks post-randomization |
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| Secondary | Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 35 weeks post-randomization |
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| Secondary | Change in Quality of Life (MCS) | Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 61 weeks post-randomization |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Arm | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Fitbit: Patients will receive a Fitbit and receive standard of care Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
| D001523 |
| Mental Disorders |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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