Endotypic Traits and Obstructive Sleep Apnea Surgery

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jul 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into how certain factors can affect the results of soft palate surgery for people with obstructive sleep apnea (OSA) and whether two medications, acetazolamide and eszopiclone, can help with other issues related to OSA. The goal is to determine if these treatments can improve breathing during sleep for those who struggle with moderate to severe OSA.

To participate in this study, individuals must be at least 21 years old and have moderate to severe OSA, meaning they experience at least 15 breathing interruptions per hour while sleeping. Participants should not have had success with standard treatments like CPAP machines or oral appliances and must be in good overall health, without serious medical conditions. Those who join the trial can expect to undergo soft palate surgery as part of their care, and they will be monitored closely to see how well the surgery and medications work together. It's also important to note that participants should not have any major allergies to the study drugs or other specific medical issues that could complicate their involvement in the trial.

Gender

ALL

Eligibility criteria

• 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.