Investigating how lung volume affects throat collapse during sleep endoscopy for sleep apnea
Characterizing the Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
This study is trying to see how changes in lung volume affect throat collapse during sleep tests in people with obstructive sleep apnea to help improve their treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05350332 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between lung volume and upper airway patency during drug-induced sleep endoscopy (DISE) in patients with obstructive sleep apnea (OSA). Participants will undergo DISE as part of their routine surgical evaluation for OSA, where a negative pressure ventilator will be used to manipulate lung volume. The goal is to better understand how lung function influences throat collapse, which could improve surgical outcomes for OSA patients. By exploring these pathophysiological factors, the study aims to enhance the selection process for surgical candidates and potentially lead to new treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with obstructive sleep apnea who are interested in surgical treatment and have consented to undergo DISE.
Not a fit: Patients with significant uncontrolled medical comorbidities or those unable to tolerate the procedures involved may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes for patients with obstructive sleep apnea.
How similar studies have performed: While the relationship between lung volume and throat collapse during DISE has not been extensively studied, similar approaches in evaluating pathophysiological factors have shown promise in improving surgical outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 yrs) willing and capable of providing informed consent * Obstructive sleep apnea (AHI ≥ 5 events/hour) * Must be willing and able to provide informed consent to participate in the study. * Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation. * Patients are evaluated and cleared by anesthesia prior to the procedure. Exclusion Criteria: * No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD). * Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery * Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia) * No incapacitating disability that interferes with execution of the protocol
Where this trial is running
Atlanta, Georgia
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jason Yu, MD — Emory University
- Study coordinator: Jason Yu, MD
- Email: jyu40@emory.edu
- Phone: 470-763-3887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.