Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP) (TOP-CPAP)
Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, Continuous Positive Airway Pressure, CPAP, Adherence, Eszopiclone, Endotype, Arousal Threshold
Eligibility Criteria
Inclusion Criteria: Ages 21-65 years old Body Mass Index <32 kg/m^2 Physician diagnosis of OSA (AHI β₯ 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 β₯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
Sites / Locations
- UC San Diego; Altman Clinical and Translational Research Institute Building
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Eszopiclone
Placebo
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible