Could two common drugs boost sleep apnea surgery success?
NCT ID NCT05953610
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study investigates whether two medications—acetazolamide and eszopiclone—can improve sleep apnea outcomes when taken after soft palate surgery. The trial includes adults with moderate to severe obstructive sleep apnea who cannot use CPAP or oral appliances. Researchers will measure changes in the apnea-hypopnea index to see if the drugs help address underlying causes like unstable breathing control or low arousal threshold.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acetazolamide and Eszopiclone
- What this could lead to
- If successful, this could point toward a combined surgical and medication approach to better control obstructive sleep apnea in people who cannot tolerate standard treatments like CPAP.
- What could go wrong
- This is a Phase 2 study with a moderate number of participants, so results may not apply to everyone. The drugs may cause side effects or not improve outcomes as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA Santa Monica Medical Center
RECRUITINGSanta Monica, California, 90401, United States
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UCLA Westwood
NOT_YET_RECRUITINGWestwood, Los Angeles, California, 90095, United States
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