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Surgery + Medication for Obstructive Sleep Apnea

Phase 2
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥21 years
Absence of uncontrolled nasal obstruction
Must not have
Subjects with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide)
Subjects on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at factors that affect results of soft palate surgery & use of drugs to treat causes of sleep apnea.

Who is the study for?
This trial is for adults over 21 with moderate to severe obstructive sleep apnea who haven't had much success with standard treatments and have a BMI under 35. Candidates should not have other major health issues, psychiatric disorders (except treated depression or mild anxiety), or be taking certain medications that affect sleep.
What is being tested?
The study is testing the effectiveness of two drugs, Acetazolamide and Eszopiclone, in combination with soft palate surgery to treat obstructive sleep apnea. It aims to see if these can address underlying causes like loop gain and arousal threshold.
What are the potential side effects?
Possible side effects of Acetazolamide may include tingling sensations, hearing disturbances, altered taste, and gastrointestinal discomfort. Eszopiclone might cause drowsiness during the day, headaches, dizziness, dry mouth or unpleasant taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I do not have any ongoing issues with blocked nose that isn't managed.
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I have moderate to severe sleep apnea.
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My medications have been the same for the last 2 months.
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I do not use sleep aids, anxiety medication, stimulants, or sedating antidepressants.
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I have not had any throat surgery except for a tonsillectomy.
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I do not have any brain, heart, or lung disorders.
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I do not have any sleep disorders like narcolepsy or insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had issues with electrolyte imbalance or adrenal problems.
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I am not taking ketoconazole or strong CYP3A4 inhibitors.
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I have severe kidney or liver disease.
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I am on high-dose aspirin therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apnea-hypopnea index
Other study objectives
Arousal threshold
Loop gain
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Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Acetazolamide/EszopicloneExperimental Treatment2 Interventions
Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
Group II: AcetazolamideExperimental Treatment1 Intervention
Treatment with acetazolamide 500 mg nightly for 1 month.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,039 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,181 Total Patients Enrolled

Media Library

Soft Palate Surgery (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05953610 — Phase 2
Obstructive Sleep Apnea Research Study Groups: Acetazolamide, Acetazolamide/Eszopiclone
Obstructive Sleep Apnea Clinical Trial 2023: Soft Palate Surgery Highlights & Side Effects. Trial Name: NCT05953610 — Phase 2
Soft Palate Surgery (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05953610 — Phase 2
~100 spots leftby Aug 2027
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