Targeted therapy to improve CPAP use in obstructive sleep apnea patients
Endotype-Targeted Therapy to Rescue OSA Patients Struggling with CPAP Adherence (TOP-CPAP): a Pilot Trial
This study is testing if a sleep medication can help people with obstructive sleep apnea use their CPAP machines more regularly.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05951023 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve adherence to CPAP therapy in patients with obstructive sleep apnea (OSA) by using a targeted drug intervention. Patients with low CPAP usage will be randomly assigned to receive either eszopiclone, a hypnotic medication, or a placebo for two weeks. The study will assess whether eszopiclone can increase the amount of time patients use CPAP each night, particularly focusing on those with a low arousal threshold. The trial will also explore the mechanisms behind any changes in CPAP adherence and its impact on sleep apnea severity and related symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 with a physician diagnosis of OSA and low CPAP adherence.
Not a fit: Patients with high side effect scores from CPAP or those with severe sleepiness or safety-critical professions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance CPAP adherence, leading to better management of obstructive sleep apnea and improved patient outcomes.
How similar studies have performed: While targeted interventions for CPAP adherence are limited, this approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California
- UC San Diego; Altman Clinical and Translational Research Institute Building — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Christopher N Schmickl, MD, PhD — University of California, San Diego
- Study coordinator: Pamela DeYoung, RPSGT
- Email: sleepresearch@health.ucsd.edu
- Phone: 858 246 2183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.