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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK115468 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months.
The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo).
126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).
Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments.
There is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients.
SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Active Comparator | Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. |
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| Medication- Trazodone | Active Comparator | Trazodone (50-100 mg): |
|
| Medication- Placebo | Placebo Comparator | Placebo (for trazodone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) Short-term | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention | Week 7 |
| Insomnia Severity Index (ISI) Long-term | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention | Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj Mehrotra, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Kidney Centers | Seattle | Washington | 98122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38224591 | Derived | Mehrotra R, Cukor D, McCurry SM, Rue T, Roumelioti ME, Heagerty PJ, Unruh M. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188. doi: 10.7326/M23-1794. Epub 2024 Jan 16. | |
| 33081705 | Derived | Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x. |
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126 participants completed baseline measures before group assignment, including patient reported outcomes collected via Computer Assisted Telephone Interview (CATI) and nights using sleep aid on sedatives&hypnotics CRF. Most (115) also completed baseline Actigraphy, although this was not required for study entry (randomization).
923 patients screened with Insomnia Severity Index (ISI). Of 411 identified as having insomnia (ISI score >=10),179 declined study participation and 106 met exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT-I | Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. |
| FG001 | Medication- Trazodone | Trazodone (50-100 mg): Trazodone: trazodone tablet |
| FG002 | Medication- Placebo | Placebo (for trazodone) Placebo: Inactive pill manufactured to mimic trazodone tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT-I | Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Insomnia Severity Index (ISI) Short-term | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
|
6 months
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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 | CBT-I | Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization / Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization / Death | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raj Mehrotra | University of Washington | 206-221-7138 | rmehrotr@uw.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 | Jun 10, 2020 | Dec 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2021 | Dec 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D010879 | Piperazines |
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SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
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The investigator, the participant, and the care provider will be blinded to the drug assignment (trazodone vs. placebo) for those subjects randomized into the medication intervention arm.
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| Trazodone | Drug | trazodone tablet |
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| Placebo | Drug | Inactive pill manufactured to mimic trazodone tablets. |
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Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention |
| Week 25 |
| Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention | Week 7 |
| Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention | Week 25 |
| Objective Measure of Sleep - Short-term | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention | Week 7 |
| Objective Measure of Sleep - Long-term | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention | Week 25 |
| BG001 | Medication- Trazodone | Trazodone (50-100 mg): Trazodone: trazodone tablet |
| BG002 | Medication- Placebo | Placebo (for trazodone) Placebo: Inactive pill manufactured to mimic trazodone tablets. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Time since starting dialysis, months | Median | Inter-Quartile Range | months |
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| OG001 | Medication- Trazodone | Trazodone (50-100 mg): Trazodone: trazodone tablet |
| OG002 | Medication- Placebo | Placebo (for trazodone) Placebo: Inactive pill manufactured to mimic trazodone tablets. |
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| Primary | Insomnia Severity Index (ISI) Long-term | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term | Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 7 |
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| Secondary | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 25 |
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| Secondary | Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Mean | 95% Confidence Interval | days | Week 7 |
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| Secondary | Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention | The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25. | Posted | Mean | 95% Confidence Interval | days | Week 25 |
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| Secondary | Objective Measure of Sleep - Short-term | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention | N=119 participants had at least one time point (week 0, week 7, and/or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time in bed asleep | Week 7 |
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| Secondary | Objective Measure of Sleep - Long-term | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention | N=119 participants had at least one time point (week 0, week 7, or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time in bed asleep | Week 25 |
|
|
|
| 2 |
| 43 |
| 10 |
| 43 |
| 14 |
| 43 |
| EG001 | Medication- Trazodone | Trazodone (50-100 mg): Trazodone: trazodone tablet | 3 | 42 | 16 | 42 | 20 | 42 |
| EG002 | Medication- Placebo | Placebo (for trazodone) Placebo: Inactive pill manufactured to mimic trazodone tablets. | 3 | 41 | 15 | 41 | 14 | 41 |
| Hospitalization / Death | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hospitalization / Death | Endocrine disorders | Systematic Assessment |
|
| Hospitalization / Death | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization / Death | Infections and infestations | Systematic Assessment |
|
| Hospitalization / Death | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization / Death | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hospitalization / Death | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization / Death | Renal and urinary disorders | Systematic Assessment |
|
| Hospitalization / Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization / Death | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization / Death | Vascular disorders | Systematic Assessment |
|
| Hospitalization / Death | Cardiac disorders | Systematic Assessment |
|
| Hospitalization / Death | Endocrine disorders | Systematic Assessment |
|
| Hospitalization / Death | Eye disorders | Systematic Assessment |
|
| Hospitalization / Death | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization / Death | Infections and infestations | Systematic Assessment |
|
| Hospitalization / Death | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization / Death | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hospitalization / Death | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization / Death | Nervous system disorders | Systematic Assessment |
|
| Hospitalization / Death | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization / Death | Renal and urinary disorders | Systematic Assessment |
|
| Hospitalization / Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization / Death | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospitalization / Death | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization / Death | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
| D011725 | Pyridines |