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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
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
Pclose
+1 moreTrial 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
1,554 Previous Clinical Trials
10,263,964 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,057 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no psychiatric conditions, except possibly treated depression or mild anxiety.I am not taking ketoconazole or strong CYP3A4 inhibitors.My sleep study shows no complete blockage caused by my tongue.I am 21 years old or older.I do not have any ongoing issues with blocked nose that isn't managed.I have had issues with electrolyte imbalance or adrenal problems.You have problems with drinking alcohol or using drugs.I have moderate to severe sleep apnea.You haven't had a near-miss or been in a car accident caused by feeling sleepy in the past year.You have fewer than 5 central or mixed apnea events per hour.You cannot tolerate using a positive airway pressure machine for at least 2 hours every night for at least 5 nights a week.My tonsils are not significantly enlarged.My medications have been the same for the last 2 months.I do not use sleep aids, anxiety medication, stimulants, or sedating antidepressants.I have agreed to undergo palate surgery.I have not had any throat surgery except for a tonsillectomy.You cannot use or are not a good choice for a mouth device.You have had a bad reaction to either of the two study drugs in the past.I do not have any brain, heart, or lung disorders.You drink fewer than three caffeinated beverages daily.You had a serious allergic reaction to sulfonamide drugs in the past.I do not have any sleep disorders like narcolepsy or insomnia.You weigh less than a certain amount for your height.I have severe kidney or liver disease.I am on high-dose aspirin therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Acetazolamide
- Group 2: Acetazolamide/Eszopiclone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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