Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
The study design is a randomized, controlled clinical trial to test the hypothesis that arousal threshold (ArTH) will affect how individuals with obstructive sleep apnea (OSA, Apnea-Hypopnea Index (AHI) of 10/hour of higher) respond to CPAP therapy regarding adherence and cognitive function (executive function). Investigators hypothesize that raising ArTH with eszopiclone will improve adherence to CPAP and neurocognitive function with CPAP therapy. Investigators also hypothesize that a lower baseline ArTH is associated with worse CPAP adherence, while a higher baseline ArTH is associated with improved neurocognitive outcomes with CPAP therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent.
Polysomnography AHI ≥ 10 per hour of sleep and/or
Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording
Disqualifiers
Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)
Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs [e.g., zoldpidem], benzodiazepines, non-selective antihistamines, trazodone, opiates, barbituates)
Known hypersensitivity reaction to eszopiclone
Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance)
Trial design
Design model
Parallel
Treatments tested in this trial
Eszopiclone
Drug3mg for \< 65 and 2mg for ≥ 65 years
Placebo
DrugMatched placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: EszopicloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
CPAP adherence
Mean daily average of CPAP use over 3 months
Time frame
Daily over 3 months2
Flanker inhibitory control and attention test
Executive function is assessed using the validated NIH Toolbox Cognition Battery's Flanker inhibitory control and attention test. In a Flanker task, participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, typically two on either side). Primary outcome is the overall percent of correct responses in incongruent trials.
Time frame
Baseline, 1-, 2- and 3-monthsSecondary outcomes
1
Mean Epworth Sleepiness Scale score Scores
Sleep questionnaire of subjective sleepiness. Total score range of 0-24; scores above 10 suggest excessive sleepiness.
Time frame
Baseline, 1-, 2-and 3-months2
Mean Functional Outcomes of Sleep Questionnaire (FOSQ) short form score
Measures how sleepiness affects daily life, with scores ranging from 5-20. Higher scores indicate better functioning and less impairment.
Time frame
Baseline, 1-, 2-and 3-months3
Mean Insomnia Severity Index score (ISI) Scores
ISI is a validated 7-question survey. The total score range is 0-28 with higher scores indicating more severe insomnia.
Time frame
Baseline, 1-, 2-and 3-months4
Mean PROMIS Sleep Disturbance score Scores
T-score mean of 50 and a standard deviation (SD) of 10. Higher scores indicating more sleep disturbance.
Time frame
Baseline, 1-, 2-and 3-monthsOther outcomes
1
Flow mediated vasodilation (FMD) - exploratory
FMD is a standard non-invasive technique for assessing endothelial function. FMD will be obtained using a standard method by a trained RA at the same time of the day after the baseline PSG and the 3-month follow-up. Two-dimensional longitudinal images will be acquired using Doppler ultrasound to assess arterial diameter and flow velocity (resting and hyperemic). Resting blood flow is estimated by time-averaging the pulsed Doppler signal obtained from a mid-vessel sample volume. The blood pressure cuff is then inflated to \>50 mmHg above systolic pressure to occlude arterial inflow for 5 minutes. A cuff is then deflated, and a pulse wave and longitudinal images are obtained at 10 seconds and 60 seconds (hyperemia). The FMD is the percent increase in vessel diameter from baseline to hyperemia.
Time frame
baseline and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
ResMed Foundation
Collaborator
Source ClinicalTrials.gov