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Rescuing OSA Patients Unable to Tolerate CPAP Using Endotype-Targeted Combination Drug Therapy: a Randomized, Double-Blind, Placebo-Controlled Trial
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox \[acetazolamide\], Lunesta \[eszopiclone\] +/- Effexor \[venlafaxine\]) on OSA severity and physiology.
Study participants will undergo three 3-day drug regimens. On days 1 and 2 of each drug regimen, subjects will take the study drugs at home; on day 3 of each drug regimen subjects will take the study drugs as part of an overnight inlab sleep study (including assessments of sleepiness/alertness, sleep quality and blood pressure). Initially subjects will take dual-therapy (acetazolamide+eszopiclone) vs placebo in random order; if sleep apnea resolved with dual-therapy, then subjects will undergo an open-label single-drug regimen (acetazolamide), else an open-label triple-drug regimen (acetazolamide + eszopiclone + venlafaxine).
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
UCSD Health - Pulmonary and Sleep Clinic
La Jolla, California, United States
Start Date
December 1, 2020
Primary Completion Date
January 27, 2022
Completion Date
January 27, 2022
Last Updated
May 29, 2024
20
ACTUAL participants
Acetazolamide
DRUG
Eszopiclone
DRUG
Placebo
DRUG
Venlafaxine
DRUG
Lead Sponsor
University of California, San Diego
Collaborators
NCT06430957
NCT04704661
Data Source & Attribution
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