Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea — RESCUE-Combo  

Obstructive Sleep Apnea Clinical Trial

Official title: Rescuing OSA Patients Unable to Tolerate CPAP Using Endotype-Targeted Combination Drug Therapy: a Randomized, Double-Blind, Placebo-Controlled Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT04639193
• Study type: Interventional
• Source: University of California, San Diego
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2020
• Completion date: January 27, 2022