NCT04639193

Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• OSA
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Acetazolamide	Acetazolamide tablet (encapsulated)
DRUG	Eszopiclone	Eszopiclone tablet (encapsulated)
DRUG	Placebo	Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone
DRUG	Venlafaxine	Venlafaxine capsule

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2020-11-20
• Last updated: 2024-05-29
• Results posted: 2024-05-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study