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Trial · NCT05616260

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryApnea Hypopnea Index14 days
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.
Primary24-hour Mean Blood Pressure14 daysBased on 24h blood pressure measurements
SecondaryHypoxic Burden14 daysRespiratory event-associated area under the desaturation curve from pre-event baseline
SecondaryReactive Hyperemia Index14 daysBased on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm.
SecondaryResponse Speed14 daysBased on 10-minute Psychomotor vigilance task (PVT)
SecondaryPatient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument14 days
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.
SecondaryPatient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument14 days
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.
SecondaryEpworth Sleepiness Scale (ESS)14 days
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.
Secondary24-hour Mean Systolic Blood Pressure14 daysBased on 24h blood pressure measurements
Secondary24-hour Mean Diastolic Blood Pressure14 daysBased on 24h blood pressure measurements
OtherMeasures of Heart-rate Variability14 daysBased on 5 min awake, supine ECG sampled at \>250Hz
OtherOvernight Memory Improvement (%)14 daysBased on Verbal Paired-Associates task
OtherShort Form 36 (SF-36) Health Survey14 days
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.
OtherSleep Apnea Traits with special focus on loop gain14 daysQuantified 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.

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