Trial · NCT05804084
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apnea Hypopnea Index (AHI) | 4 weeks | The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \>=3% desaturation or cortical arousal) per hour of sleep. Alternative definitions of the AHI will be explored as well (e.g. hypopneas based on 4% desaturations, or position/sleep-stage specific AHIs). |
| Secondary | Hypoxic Burden (percent*minute/hour) | 4 weeks | Respiratory event-associated area under the desaturation curve from pre-event baseline (continuous outcome with units being "percent\*minutes/hour") |
| Secondary | Overnight Memory Improvement (change in percentage points) | 4 weeks | Based on Verbal Paired-Associates task |
| Secondary | Cognitive function composite score | 4 weeks | Total composite score from the National Institutes of Health (NIH) Toolbox based on 7 cognitive domains which will also be explored separately and via subscales (i.e., (Fluid and Crystaliized Cognition Composite Scores). These scores are based on a T-Score metric, with a normative mean of 50 and an SD of 10. Higher scores indicate better cognitive function. |
| Secondary | Response Speed | 4 weeks | 10-minute Psychomotor vigilance task (PVT) |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument | 4 weeks | Based on response pattern scoring, the PROMIS 8-item SDA score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10. Higher t-scores reflect greater sleep disturbance. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument | 4 weeks | Based on response pattern scoring, the PROMIS 8-item SRI score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10. Higher t-scores reflect greater sleep-related impairment. |
| Secondary | Epworth Sleepiness Scale (ESS) Score | 4 weeks | The ESS is an 8-item instrument assessing the likelihood of dozing off in 8 different situations with points for each item ranging from 0 to 3 (0 = would never doze off; 3 = high chance of dozing off). The points for each item are summed up, thus the total score ranges from 0 to 24, with higher ESS scores indicating greater sleepiness. |
| Secondary | Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10) | 4 weeks | The FOSQ-10 is a 10-item instrument assessing sleep-related quality of life across 5 domains (general productivity, activity level, vigilance, social outcomes, intimacy and sexual relationships). Each item is scored on a scale ranging from 1 to 4 (a higher number indicates a better functional status for that item). The mean scores of the 5 subscales are averaged and then multiplied by 5 to calculate a total summary score ranging from 5-20 (higher scores indicate better functional outcomes). The main focus will be on the total summary score, but scores from subscales will be explored as well. |
| Secondary | Short Form 36 (SF-36) Health Survey | 4 weeks | The SF36 is a widely used questionnaire to measure general health-related quality of life across 8 domains (e.g. physical functioning, Energy/fatigue, Social functioning, etc). The score for each of the 8 domains ranges from 0 to 100, with greater scores indicating better health-related quality fo life in this domain. |
| Secondary | Mean blood pressure | 4 weeks | Average mean blood pressure based on two resting blood pressure measurements. Systolic/diastolic blood pressures will be explored as well. |
| Secondary | Reactive hyperemia index | 4 weeks | Based on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm. |
| Other | Sleep Apnea Traits with special focus on loop gain | 4 weeks | Quantified from routine polysomnography data. |
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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GET https://conductscience.org/api/trials/v1/NCT05804084/registered