New pill helps sleep apnea patients stick with CPAP
NCT ID NCT05951023
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a safe sleep aid could help people with obstructive sleep apnea use their CPAP machine more each night. Many patients struggle to keep the mask on all night, often because they wake up easily. The trial gave a medication to raise the sleepers' arousal threshold, aiming to improve CPAP adherence. 42 adults with sleep apnea who had low CPAP use participated.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ages 21-65 years old * Body Mass Index \<32 kg/m\^2 * Physician diagnosis of OSA (AHI ≥ 10) based on a clinical sleep study within the past 2 years (subjects who report a history of sleep apnea but do not have a sleep study report from the past 2 years available will be offered an overnight home sleep apnea test to verify OSA diagnosis) * AHI\>5/h on the overnight research sleep study #1 * Subject had the opportunity to use CPAP for at least 1 month * Continuous positive airway pressure (CPAP) data can be queried remotely and shows usage 0.5-4h/night (based on most recent 30 day period) * Interest to continue trying CPAP Exclusion Criteria: * "SAVE CPAP Side Effect Score" \>3 (1 point for each: dry mouth, nasal symptoms, CPAP pressure intolerance, claustrophobia, noise problems, soreness/skin irritation, mask fit/leak problems) * Any high-risk features: Epworth sleepiness score ≥18, safety-critical profession (e.g., commercial driver), prior sleep-related car accident, substantial hypoxemia during sleep \[SpO2\<70% for \>5min\] or awake \[SpO2\<92%\] * Any uncontrolled medical/psychiatric condition, or safety concern based on MD judgment * Pregnancy/Breastfeeding (current or planned during the next month) * Inability to complete study procedures, such as questionnaires that are only available/validated in English * Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy * Unwilling or unable to withhold CPAP during polysomnography * Presence of tracheostomy * Hospitalization within the past 90 days * Allergy to the study drug * Regular use of opioids, or benzodiazepines * Chronically using study drug or other hypnotic * Significant circadian rhythm disorder or sleepwalking as an adult * Active illicit substance use or \>3 oz nightly alcohol use * Prisoners * Cognitive impairment, unable to provide consent, or unable to carry out research procedures * Safety concern based on MD judgment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UC San Diego; Altman Clinical and Translational Research Institute Building
La Jolla, California, 92121, United States
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