Detecting upper airway obstruction during sleep using high-resolution manometry
Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep
This study is testing a new way to find blockages in the airway during sleep in adults and children with obstructive sleep apnea to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 172 (estimated) |
| Ages | 5 Years to 90 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04139499 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess upper airway obstruction in patients with obstructive sleep apnea (OSA) using high-resolution manometry during drug-induced sleep endoscopy. It targets both adults and children who are undergoing sleep endoscopy as part of their standard clinical care. The study will evaluate the effectiveness of this technique in identifying airway obstructions that contribute to OSA, which is a significant public health concern. By understanding these obstructions better, the study seeks to improve treatment strategies for patients suffering from OSA.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 and children aged 5-17 who are undergoing sleep endoscopy for suspected obstructive sleep apnea or related airway issues.
Not a fit: Patients who do not have obstructive sleep apnea or are not undergoing relevant surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and improved treatment options for patients with obstructive sleep apnea.
How similar studies have performed: While the use of high-resolution manometry in this context is relatively novel, similar studies have shown promise in improving the understanding and management of obstructive sleep apnea.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ADULTS * Age 18-90 * Any participant undergoing sleep endoscopy as part of standard clinical care would be eligible. This entails physician concern for sleep-disordered breathing and corresponding questionnaire and/or polysomnogram results supporting a diagnosis of obstructive sleep apnea. * Participants without apnea are eligible, provided they are undergoing tonsillectomy or bronchoscopy for either chronic tonsillitis or airway assessment without concern for history of sleep apnea. * Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential. CHILDREN * Age 5-17 * Any patients undergoing sleep endoscopy as part of standard clinical care would be eligible. * Participants undergoing either tonsillectomy for chronic tonsillitis or bronchoscopy for airway assessment. * Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential. Exclusion Criteria: * Participant desire to avoid added anesthesia time. * Inability to safely tolerate the added anesthesia time (about 5-10 minutes) for the experiment (as judged by either otolaryngologist or anesthesiologist). * Pregnant women * Vulnerable groups (i.e., prisoners, individuals lacking consent capacity, individuals unable to read the consent form).
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Timothy M Mcculloch, MD, FACS — University of Wisconsin, Madison
- Study coordinator: Suzan Abdelhalim, MD, MPH
- Email: abdelhalim@surgery.wisc.edu
- Phone: 6082652470
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.