Examining surgery and medications for obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the outcomes of soft palate surgery and the effects of medications like acetazolamide and eszopiclone on patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate positive airway pressure. It involves a cohort of 150 participants undergoing drug-induced sleep endoscopy to measure upper airway closing pressure and assess OSA severity before and six months after surgery. The study aims to identify underlying mechanisms of OSA and evaluate treatment efficacy through a randomized crossover design for those who do not achieve resolution of OSA post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCLA Santa Monica Medical Center
  Santa Monica, California, United States Recruiting
• UCLA Westwood
  Westwood, Los Angeles, California, United States Not yet recruiting

Study contacts

• Study coordinator: Eric J Kezirian, MD, MPH
• Email: EKezirian@mednet.ucla.edu
• Phone: 32344257904242596559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.