Endotypic Traits and Obstructive Sleep Apnea Surgery

Phase 2

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Acetazolamide 500 MG QHS; Drug: Eszopiclone 3 mg QHS

• Registration Number: NCT05953610
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).

Detailed Description

This is a prospective cohort (observational) study of 150 participants with moderate to severe obstructive sleep apnea (OSA) unable to tolerate positive airway pressure who are undergoing drug-induced sleep endoscopy (DISE), including measurement of upper airway closing pressure (Pclose), and tissue-repositioning soft palate surgery. Before and 6 months after surgery, the investigators will measure OSA severity (apnea-hypopnea index) with sleep studies (polysomnograms). Using a recently-validated polysomnography-based signal processing algorithm, the investigators will systematically assess the underlying mechanisms of OSA (traits) and airflow shape (consistent with palate obstruction). The expected 90 participants without resolution of OSA after surgery (surgery failures) will participate in an experimental randomized crossover study of acetazolamide (1 month) and acetazolamide/eszopiclone combination (1 month). Polysomnograms will be performed with each treatment, with algorithm-based determination of traits.

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Study Start: 2024-01-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acetazolamide/Eszopiclone	Acetazolamide 500 MG QHS	Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
Acetazolamide/Eszopiclone	Eszopiclone 3 mg QHS	Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
Acetazolamide	Acetazolamide 500 MG QHS	Treatment with acetazolamide 500 mg nightly for 1 month.

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index	6 months	apneas plus hypopneas per hour of sleep

Trial Locations

Locations (2)

UCLA Santa Monica Medical Center; 🇺🇸 Santa Monica, California, United States

UCLA Westwood; 🇺🇸 Westwood, California, United States