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Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea

NCT04639193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-29

Study results available
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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.

Conditions

Interventions

DRUG

Acetazolamide

Acetazolamide tablet (encapsulated)

DRUG

Eszopiclone

Eszopiclone tablet (encapsulated)

DRUG

Placebo

Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone

DRUG

Venlafaxine

Venlafaxine capsule

Sponsors & Collaborators

Principal Investigators

  • Christopher Schmickl, MD, PhD · Associate Physician and Postdoctoral Fellow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-01-27
Completion
2022-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639193 on ClinicalTrials.gov