Surgery + Medication for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).
Will I have to stop taking my current medications?
The trial requires that your medications have been stable for at least 2 months, and you cannot use hypnotics, anxiolytics, stimulants, or sedating antidepressants. If you are on these medications, you may need to stop them before participating.
Is the combination of surgery and medication for obstructive sleep apnea generally safe for humans?
Uvulopalatopharyngoplasty (UPPP), a common surgery for obstructive sleep apnea, is generally safe but can have complications, with a serious complication rate of 3.5% and a mortality rate of 0.4%. Proper surgical techniques can minimize risks, but some patients may experience temporary pain, nasal regurgitation, or a nasal voice, which are usually reversible.12345
How is the treatment of Soft Palate Surgery for Obstructive Sleep Apnea different from other treatments?
Soft Palate Surgery, including techniques like uvulopalatopharyngoplasty (UPPP) and its modifications, is unique because it focuses on reconstructing and preserving tissue to minimize side effects while improving airway function. Unlike traditional UPPP, which is more excisional, newer methods like expansion sphincterpharyngoplasty aim to stiffen and enlarge the airway, potentially offering better outcomes with fewer complications.678910
What data supports the effectiveness of the treatment for obstructive sleep apnea?
Research shows that transpalatal advancement pharyngoplasty, a modification of traditional surgery, can effectively increase airway size and reduce respiratory disturbance in patients with obstructive sleep apnea. In a study, 67% of patients who underwent this procedure alone experienced a significant decrease in their respiratory disturbance index, indicating improved breathing during sleep.6891112
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Assessment
Participants undergo drug-induced sleep endoscopy and tissue-repositioning soft palate surgery. OSA severity is measured before surgery.
Treatment
Participants with unresolved OSA after surgery receive acetazolamide for 1 month, followed by acetazolamide/eszopiclone combination for another month.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of OSA severity and other traits.
What Are the Treatments Tested in This Trial?
Interventions
- Acetazolamide
- Eszopiclone
- Soft Palate Surgery
Soft Palate Surgery is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator