Endotypic Traits and Obstructive Sleep Apnea Surgery

1.0

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).

2024-01-07

2027-08-31

2027-08-31

Recruiting

Early phase I

150

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective cohort study will include an anticipated 150 study participants undergoing soft palate surgery. The randomized crossover (interventional) study will include the anticipated 90 who do not achieve successful treatment of their obstructive sleep apnea with surgery.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-03-13