Endotypic Traits and Obstructive Sleep Apnea Surgery

NCT05953610 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 1.0R01HL160993
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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).

Conditions

Obstructive Sleep Apnea

Keywords

surgery; loop gain; arousal threshold

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index

  apneas plus hypopneas per hour of sleep

  6 months

Other Outcomes (4)

• Pclose

  6 months

• Vpassive

  6 months

• Loop gain

  6 months

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Treatment with acetazolamide 500 mg nightly for 1 month.

Drug: Acetazolamide 500 MG QHS

Acetazolamide/Eszopiclone

EXPERIMENTAL

Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.

Drug: Acetazolamide 500 MG QHS; Drug: Eszopiclone 3 mg QHS

Interventions

Acetazolamide 500 MG QHS DRUG

Acetazolamide

Acetazolamide; Acetazolamide/Eszopiclone

Eszopiclone 3 mg QHS DRUG

Eszopiclone

Acetazolamide/Eszopiclone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥21 years;
• moderate to severe OSA (obstructive AHI ≥ 15 events/hour);
• central/mixed apnea index \<5 events/hour;
• intolerance of positive airway pressure (defined as use \< 2 hours/night at least 5 nights/week);
• intolerance or poor candidate for oral appliance;
• participant has provided informed consent for palate surgery as part of their standard of care;
• tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);
• DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);
• medications stable for ≥2 months;
• body mass index \<35 kg/m2;
• absence of uncontrolled nasal obstruction;
• no prior pharyngeal surgery other than tonsillectomy;
• no neurologic, cardiac or pulmonary disorders;
• absence of psychiatric disorder except for treated depression or mild anxiety;
• no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;

You may not qualify if:

• history of allergic reaction to either of the study drugs;
• subjects with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;
• subjects with a history of hypersensitivity to either of the two study drugs;
• subjects who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;
• subjects with severe kidney disease or severe liver disease;
• subjects with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);
• subjects on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels);
• pregnancy; and
• alcohol or substance abuse.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UCLA Santa Monica Medical Center

Santa Monica, California, 90401, United States

RECRUITING

UCLA Westwood

Westwood, Los Angeles, California, 90095, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Acetazolamide; Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Pyrazines; Pyridines

Central Study Contacts

Eric J Kezirian, MD, MPH

CONTACT

32344257904242596559; EKezirian@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective cohort study will include an anticipated 150 study participants undergoing soft palate surgery. The randomized crossover (interventional) study will include the anticipated 90 who do not achieve successful treatment of their obstructive sleep apnea with surgery.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: July 20, 2023
• Study Start: January 7, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (2)