NCT05953610 Endotypic Traits and Obstructive Sleep Apnea Surgery
| NCT ID | NCT05953610 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-07 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-01-07 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05953610 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05953610 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05953610 currently recruiting?
Yes, NCT05953610 is actively recruiting participants. Contact the research team at EKezirian@mednet.ucla.edu for enrollment information.
Where is the NCT05953610 trial being conducted?
This trial is being conducted at Santa Monica, United States, Westwood, Los Angeles, United States.
Who is sponsoring the NCT05953610 clinical trial?
NCT05953610 is sponsored by University of California, Los Angeles. The trial plans to enroll 150 participants.