NCT05953610

Endotypic Traits and Obstructive Sleep Apnea Surgery

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Acetazolamide 500 MG QHS	Acetazolamide
DRUG	Eszopiclone 3 mg QHS	Eszopiclone

Timeline

• Start date: 2024-01-07
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2023-07-20
• Last updated: 2025-06-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study