Examining surgery and medications for obstructive sleep apnea

Endotypic Traits and Obstructive Sleep Apnea Surgery

This study is testing if soft palate surgery and certain medications can help people with moderate to severe obstructive sleep apnea who can't use a CPAP machine feel better and breathe easier.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 2 sites (Santa Monica, California and 1 other locations)
• Trial ID: NCT05953610 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with moderate to severe obstructive sleep apnea who are intolerant to positive airway pressure therapy.

Not a fit: Patients with uncontrolled nasal obstruction, significant psychiatric disorders, or other co-existing sleep disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with obstructive sleep apnea who do not respond to conventional therapies.

How similar studies have performed: Other studies have shown promise in similar approaches, but this specific combination of interventions is relatively novel.

Eligibility criteria

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 this trial is running

Santa Monica, California and 1 other locations

• 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

Conditions Obstructive Sleep Apnea; surgery; loop gain; arousal threshold