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| ID | Type | Description | Link |
|---|---|---|---|
| K23NR018487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse. |
|
| Control Arm | Active Comparator | Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Behavioral Sleep Intervention for Insomnia | Behavioral | The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency | time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary | immediately post-intervention (4-5weeks after the start of the intervention) |
| Sleep Latency | time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary | 3 months post intervention |
| Health Related Quality of Life (HRQOL) | RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL. | immediately post-intervention (4-5weeks after the start of the intervention) |
| Health Related Quality of Life (HRQOL) | RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL. | 3 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Wake After Sleep Onset (WASO) | time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep | immediately post intervention (4-5weeks after the start of the intervention) |
| Wake After Sleep Onset (WASO) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. The outcome measure used for this study will be number of participants who complete the dried blood spot sample, as a measure of feasibility. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Screened 180 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse. Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. |
| FG001 | Control Arm | Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up). Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse. Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sleep Latency | time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary | Posted | Mean | Standard Deviation | minutes | immediately post-intervention (4-5weeks after the start of the intervention) |
|
Adverse event data were collected at each touchpoint with participant- Weekly during the intervention, visit 2 (5 weeks after baseline), Visit 3 (17 weeks after baseline)
No difference
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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 | Intervention Arm | Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse. Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night. |
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Dried blood spot analysis was changed into a feasibility measure, given the low responses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miranda McPhillips | University of Pennsylvania | 215-898-8281 | mvarr@nursing.upenn.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 | Mar 15, 2023 | Apr 30, 2024 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2021 | Apr 28, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Active Control | Behavioral | The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. |
|
time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep |
| 3 months post intervention |
| Total Sleep Time (TST) | Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes | immediately post intervention |
| Total Sleep Time (TST) | Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes | 3 months post intervention |
| Sleep Efficiency (SE) | Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep | immediately post intervention |
| Sleep Efficiency (SE) | Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep | 3 months post intervention |
| Self- Reported Insomnia Symptoms | measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes) | immediately post intervention |
| Self- Reported Insomnia Symptoms | measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes) | 3 months post intervention |
| Self-reported Sleep Quality | measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes) | immediately post intervention |
| Self-reported Sleep Quality | measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes) | 3 months post intervention |
| Immediately post intervention |
| Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. | 3 months post intervention |
| BG001 | Control Arm | Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up). Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| subjective sleep latency | The time that it takes someone to fall asleep, from the first intention of going to sleep, in minutes. This variable is collected via sleep diary and averaged over a one week period. | Mean | Standard Deviation | minutes |
|
| subjective sleep efficiency | The percentage of time spent in bed that a person actually is asleep (time asleep/time in bed). This variable is collected via sleep diary and averaged over a one week period. | Mean | Standard Deviation | percentage |
|
| subjective total sleep time | The amount of time a person is asleep at night. This variable is collected via sleep diary and averaged over a one week period. | Mean | Standard Deviation | minutes |
|
| subjective wake after sleep onset | Mean | Standard Deviation | minutes |
|
| 36-Item Short Form Survey (SF-36) | RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health and range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health scale. | Mean | Standard Deviation | units on a scale |
|
| Insomnia Severity Index | The ISI is a validated self-report measure of insomnia. Participants answer 7 questions; scores are summed. Scores range from 0-28; higher scores indicate worse sleep (I.e., more insomnia). | Mean | Standard Deviation | scores on a scale |
|
| Pittsburgh Sleep Quality Index | This is a validated measure of self-reported sleep quality. The measure consists of 19 individual items, creating 7 components that produce one global score. Higher scores indicate worse sleep quality. | Mean | Standard Deviation | score on a scale |
|
| Number of Participants who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | this measure was a count of participants who completed the dried blood spot collections to be used for inflammatory biomarker analysis and is being used as a feasibility measure. | Count of Participants | Participants |
|
| OG001 | Control Arm | Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up). Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. |
|
|
| Primary | Sleep Latency | time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary | Lost one participant in intervention to follow-up; lost two participants in control arm to follow up and one had missing sleep diary data at follow up | Posted | Mean | Standard Deviation | minutes | 3 months post intervention |
|
|
|
| Primary | Health Related Quality of Life (HRQOL) | RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL. | lost one intervention participant and one control participant to immediate follow up | Posted | Mean | Standard Deviation | score on a scale | immediately post-intervention (4-5weeks after the start of the intervention) |
|
|
|
| Primary | Health Related Quality of Life (HRQOL) | RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL. | Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group. | Posted | Mean | Standard Deviation | score on a scale | 3 months post intervention |
|
|
|
| Secondary | Wake After Sleep Onset (WASO) | time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep | lost one intervention participant and one control participant to immediate follow up | Posted | Mean | Standard Deviation | minutes | immediately post intervention (4-5weeks after the start of the intervention) |
|
|
|
| Secondary | Wake After Sleep Onset (WASO) | time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep | Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group. | Posted | Mean | Standard Deviation | minutes | 3 months post intervention |
|
|
|
| Secondary | Total Sleep Time (TST) | Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes | lost one intervention participant and one control participant to immediate follow up | Posted | Mean | Standard Deviation | minutes | immediately post intervention |
|
|
|
| Secondary | Total Sleep Time (TST) | Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes | Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control | Posted | Mean | Standard Deviation | minutes | 3 months post intervention |
|
|
|
| Secondary | Sleep Efficiency (SE) | Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep | lost one intervention participant and one control participant to immediate follow up | Posted | Mean | Standard Deviation | percentage of time asleep | immediately post intervention |
|
|
|
| Secondary | Sleep Efficiency (SE) | Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep | Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group. | Posted | Mean | Standard Deviation | percentage of time spent asleep | 3 months post intervention |
|
|
|
| Secondary | Self- Reported Insomnia Symptoms | measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes) | Posted | Mean | Standard Deviation | score on a scale | immediately post intervention |
|
|
|
| Secondary | Self- Reported Insomnia Symptoms | measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes) | Posted | Mean | Standard Deviation | score on a scale | 3 months post intervention |
|
|
|
| Secondary | Self-reported Sleep Quality | measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes) | Posted | Mean | Standard Deviation | score on a scale | immediately post intervention |
|
|
|
| Secondary | Self-reported Sleep Quality | measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes) | Posted | Mean | Standard Deviation | score on a scale | 3 months post intervention |
|
|
|
| Other Pre-specified | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. The outcome measure used for this study will be number of participants who complete the dried blood spot sample, as a measure of feasibility. | Posted | Count of Participants | Participants | Immediately post intervention |
|
|
|
| Other Pre-specified | Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis | Systemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. | Posted | Count of Participants | Participants | 3 months post intervention |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Control Arm | Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up). Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |