Endotypic Traits and Obstructive Sleep Apnea Surgery
Overview
- Phase
- Phase 2
- Intervention
- Acetazolamide 500 MG QHS
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University of California, Los Angeles
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Apnea-hypopnea index
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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).
Detailed Description
This is a prospective cohort (observational) study of 150 participants with moderate to severe obstructive sleep apnea (OSA) unable to tolerate positive airway pressure who are undergoing drug-induced sleep endoscopy (DISE), including measurement of upper airway closing pressure (Pclose), and tissue-repositioning soft palate surgery. Before and 6 months after surgery, the investigators will measure OSA severity (apnea-hypopnea index) with sleep studies (polysomnograms). Using a recently-validated polysomnography-based signal processing algorithm, the investigators will systematically assess the underlying mechanisms of OSA (traits) and airflow shape (consistent with palate obstruction). The expected 90 participants without resolution of OSA after surgery (surgery failures) will participate in an experimental randomized crossover study of acetazolamide (1 month) and acetazolamide/eszopiclone combination (1 month). Polysomnograms will be performed with each treatment, with algorithm-based determination of traits.
Investigators
Eric J. Kezirian, MD, MPH
Professor
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Acetazolamide
Treatment with acetazolamide 500 mg nightly for 1 month.
Intervention: Acetazolamide 500 MG QHS
Acetazolamide/Eszopiclone
Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
Intervention: Acetazolamide 500 MG QHS
Acetazolamide/Eszopiclone
Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
Intervention: Eszopiclone 3 mg QHS
Outcomes
Primary Outcomes
Apnea-hypopnea index
Time Frame: 6 months
apneas plus hypopneas per hour of sleep