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Could two common drugs boost sleep apnea surgery success?

NCT ID NCT05953610

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

21 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UCLA Santa Monica Medical Center

    RECRUITING

    Santa Monica, California, 90401, United States

  • UCLA Westwood

    NOT_YET_RECRUITING

    Westwood, Los Angeles, California, 90095, United States

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