Trial · NCT04468776
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Insomnia Symptom Severity | Baseline, 6 months | Change in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Baseline ISI, Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Secondary | Number of Participants With Treatment Response of Insomnia Symptoms | Baseline, 6 months | Treatment response defined as a ≥6 point reduction in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting treatment response criteria at 6 months. |
| Secondary | Number of Participants With Remission of Insomnia Symptoms | 6 months | Remission of Insomnia symptoms defined as Insomnia Severity Index \<8 at follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting insomnia remission criteria at 6 months. |
| Other | Change in Anxiety and Depression | Baseline, 6 months | The Patient Health Questionnaire (PHQ-8) is an 8-item self-report measure for assessing depression severity. The items are summed to yield a score between 0 and 24, with higher scores indicating more frequent depression symptoms. The Generalized Anxiety Disorder (GAD-7) Scale is a 7-item self-report measure used for screening and assessing severity of GAD. The items are summed to yield a score between 0 and 21, with higher scores indicating more severe GAD symptoms. Change is estimated mean change in mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Cognitive Function | Baseline, 6 months | The PROMIS Cognitive Function Short Form (8a) is an 8-item self-report measure related to executive functioning. Individual item responses range from 1 (very often) to 5 (never) and the total raw score is converted to standardized T-scores using established United States general adult population with a mean of 50 and a standard deviation of 10. Higher T-scores signify better cognitive function. Estimated mean change in T-score from baseline to follow-up is reported from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. Positive change indicates improved cognitive function. |
| Other | Change in Patient-Reported Health | Baseline, 6 months | The PROMIS Global Health is a 10-item self-report measure that assess general health and functioning. Item responses range from 1 (excellent/none) to 5 (poor/always) and a single pain item ranges from 0 (no pain) to 10 (worst pain). Physical and mental health sub-scores are calculated from 4 items each, and the total raw sub-scores (range: 4-20) are converted to T-scores using distributions standardized to mean 50 (SD 10) for the US general population. Higher score indicates greater health-related quality of life. The Medical Outcome Survey (SF-12) is a 12-item self-report measure of physical and mental health. The Physical Component Score (PCS) and Mental Component Score (MCS) sub-scores range 0-100; higher score indicates better health. Change is estimated mean change from baseline to follow-up in mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Fatigue | Baseline, 6 months | The PROMIS Fatigue instrument is a 7-item self-report measure that assesses recent fatigue and how fatigue interfered with daily activities. Scores range from 7 to 35, with higher scores indicating greater fatigue. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Pain Intensity and Interference | Baseline, 6 months | The PROMIS Pain Intensity scale is a 3-item instrument used to assess how much pain a person has. Scores range from 3-15, with higher scores indicating greater pain intensity. The PROMIS Pain Interference scale is a 6-item instrument used to assess the consequences of pain in different domains of daily life. Scores range from 6-30, with higher scores indicating greater interference. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Pittsburgh Sleep Quality Index | Baseline, 6 months | The Pittsburgh Sleep Quality Index (PSQI) is an 18-item self-report measure that assesses sleep quality in the past month. These items are combined into seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction). The seven component scores are added to produce a global sleep quality score ranging from 0 to 21; higher total score indicates worse sleep quality. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Daytime Sleepiness | Baseline, 6 months | The Epworth Sleepiness Scale (ESS) is an 8-item self-report measure that assesses daytime sleepiness by asking about the likelihood of dozing in certain situations. Individual items are summed to yield the ESS score between 0 (never doze) to 24 (doze a lot) with higher scores indicating more sleepiness. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Change in Munich Chronotype | Baseline, 6 months | The Munich Chronotype Questionnaire (MCTQ) is a self-report scale to assess sleep structure, patterns, duration, and quality. The chronotype sub-score represents the mid-point time of sleep which is converted to a numeric value by adding the hour plus minutes divided by 60. Greater values indicate later chronotype. Positive change values indicate a shift to later chronotype. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. |
| Other | Dysfunctional Beliefs and Attitudes About Sleep | Baseline, 6 months | Dysfunctional Beliefs and Attitudes about Sleep (DBAS) Scale is a 16-item instrument used to evaluate dysfunctional thoughts related to insomnia. Each item is scored 0-10 and the total is the average of the 16 item scores (range 0-10), with higher scores indicating greater dysfunctional beliefs about sleep. |
| Other | Number of Participants With Insomnia Treatment Side Effects | 1 month, 9 weeks, 6 months | Side effects (frequency, severity, impairment) are recorded via self-report adapted from the FIBSER. Scores range from 0 (no side effects; better) to 21 (worse). Side effects were analyzed if participant reported severity of greater than moderate and/or frequency greater than 50% of the time. Count of participants meeting the threshold for analysis up through the 6 month follow-up. |
| Other | Medication Adherence | 1 month, 9 weeks, 6 months, 9 months, 12 months | Medication use is assessed using self-reported prescription, over-the-counter, and supplement name and frequency. Count of participants reporting zolpidem or trazodone use for sleep is recorded for adherence to the Medication and Combination treatment arms. |
| Other | Self-reported Falls | 1 month, 9 weeks, 6 months | Participants self-reported number of falls including context, location, and consequences of falls. Count of participants with one or more falls up through the 6 month follow-up. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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