Trial · NCT06404112
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in total score of the PROMIS 8b SD to assess sleep disturbance | Baseline, End of Intervention (Day 63) | The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance. |
| Primary | Change in sleep onset variability, assessed using a wearable device | Baseline, End of Intervention (Day 63) | A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI |
| Secondary | Change in total score of the PROMIS 8a SRI to assess sleep-related impairment | Baseline, End of Intervention (Day 63) | The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with \> 55 1 SD above population mean. |
| Secondary | Change in PROMIS 10a Fatigue score | Baseline, End of Intervention (Day 63) | The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much). |
| Secondary | Change in an objective neurocognitive battery score | Baseline, End of Intervention (Day 63) | |
| Secondary | Change in ECog2 measure | Baseline, End of Intervention (Day 63) | Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete. |
| Secondary | Change in PASC Symptom Questionnaire responses | Baseline, End of Intervention (Day 63) | Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC. |
| Secondary | Change in total score from ISI (Insomnia Severity Index) | Baseline, End of Intervention (Day 63) | The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks. |
| Secondary | Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary | Baseline, End of Intervention (Day 63) | Sleep onset time will be assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary | Baseline, End of Intervention (Day 63) | Nocturnal sleep duration will be assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary | Baseline, End of Intervention (Day 63) | 24-hour sleep duration will be assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary | Baseline, End of Intervention (Day 63) | Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary |
| Secondary | Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker | Baseline, End of Intervention (Day 63) | Nocturnal sleep duration will be assessed by activity tracker |
| Secondary | Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker | Baseline, End of Intervention (Day 63) | 24-hour sleep duration will be assessed by activity tracker |
| Secondary | Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker | Baseline, End of Intervention (Day 63) | Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker |
| Secondary | Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker | Baseline, End of Intervention (Day 63) | Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary |
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.
For software
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