Recruiting
Phase 2

Observational Study

Sponsor:

UCLA

Code:

NCT05953610

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Acetazolamide 500 MG QHS

Eszopiclone 3 mg QHS

Study Details

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

Study ID

NCT05953610

Start date

Jan 7, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion criteria are:

1. age ≥21 years;
2. moderate to severe OSA (obstructive AHI ≥ 15 events/hour);
3. central/mixed apnea index <5 events/hour;
4. intolerance of positive airway pressure (defined as use < 2 hours/night at least 5 nights/week);
5. intolerance or poor candidate for oral appliance;
6. participant has provided informed consent for palate surgery as part of their standard of care;
7. tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);
8. DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);
9. medications stable for ≥2 months;
10. body mass index <35 kg/m2;
11. absence of uncontrolled nasal obstruction;
12. no prior pharyngeal surgery other than tonsillectomy;
13. no neurologic, cardiac or pulmonary disorders;
14. absence of psychiatric disorder except for treated depression or mild anxiety;
15. no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;
16. no use of hypnotics, anxiolytics, stimulants, or sedating antidepressants;
17. no near-miss or prior motor vehicle crash due to sleepiness in past 12 months; and
18. <3 caffeinated beverages daily.

Exclusion criteria are:

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acetazolamide

Treatment with acetazolamide 500 mg nightly for 1 month.

experimental: Acetazolamide/Eszopiclone

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

Interventions

Acetazolamide 500 MG QHS

Acetazolamide

Eszopiclone 3 mg QHS

Eszopiclone

Primary outcome measure

  • Apnea-hypopnea index [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

UCLA Santa Monica Medical Center

Recruiting

Santa Monica, California, United States, 90401

Principal Investigator:

Eric Kezirian, MD, MPH

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • surgery
  • loop gain
  • arousal threshold

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-07-01.