Actively Recruiting

Phase 2
Age: 21Years +
All Genders
NCT05953610

Endotypic Traits and Obstructive Sleep Apnea Surgery

Led by University of California, Los Angeles · Updated on 2025-06-27

150

Participants Needed

2

Research Sites

242 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Endotypic Traits and Obstructive Sleep Apnea Surgery

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older
  • Moderate to severe obstructive sleep apnea with apnea-hypopnea index 15 events/hour or higher
  • Central or mixed apnea index less than 5 events/hour
  • Unable to tolerate positive airway pressure therapy (less than 2 hours per night, 5 nights per week)
  • Intolerance or poor candidate for oral appliance
  • Provided informed consent for soft palate surgery as part of standard care
  • Tonsil size between 0 and 2+, without markedly enlarged tonsils
  • Drug-induced sleep endoscopy shows no complete tongue-related obstruction
  • Medications stable for 2 months or more
  • Body mass index less than 35 kg/m2
  • No uncontrolled nasal obstruction
  • No prior pharyngeal surgery except tonsillectomy
  • No neurologic, cardiac, or pulmonary disorders
  • No psychiatric disorder except treated depression or mild anxiety
  • No co-existing sleep disorder such as narcolepsy, chronic insomnia, or restless legs syndrome
  • No use of hypnotics, anxiolytics, stimulants, or sedating antidepressants
  • No near-miss or prior motor vehicle crash due to sleepiness in the past 12 months
  • Less than 3 caffeinated beverages daily
Not Eligible

You will not qualify if you...

  • History of allergic reaction to acetazolamide or eszopiclone
  • History of serious allergic reaction such as Stevens-Johnson syndrome to sulfonamides
  • History of hypersensitivity to either study drug
  • On high-dose aspirin therapy due to risk of metabolic acidosis
  • Severe kidney disease or severe liver disease
  • History of electrolyte imbalance or adrenal insufficiency
  • Taking ketoconazole or other strong CYP3A4 inhibitors
  • Pregnancy
  • Alcohol or substance abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

UCLA Santa Monica Medical Center

Santa Monica, California, United States, 90401

Actively Recruiting

2

UCLA Westwood

Westwood, Los Angeles, California, United States, 90095

Not Yet Recruiting

Loading map...

Research Team

E

Eric J Kezirian, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here