| NCT ID | NCT05050383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 241 participants |
| Start Date | 2021-11-12 |
| Primary Completion | 2026-09 |
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.
This trial targets 241 participants in total. It began in 2021-11-12 with a primary completion date of 2026-09.
⚠ 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
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow and pressure-area relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep. The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .
Eligibility Criteria
Inclusion Criteria: 1. Adults (≥ 18yrs) willing and capable of providing informed consent. 2. English-speaking \& able to give Informed Consent. 3. Referred or scheduled for clinically indicated DISE procedure. 4. Seeking CPAP alternatives for treatment of sleep disordered breathing. Exclusion Criteria: * None
Contact & Investigator
Raj C Dedhia, MD, MSCR
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT05050383 clinical trial?
This trial is open to participants of all sexes, aged 18 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.
Is NCT05050383 currently recruiting?
Yes, NCT05050383 is actively recruiting participants. Contact the research team at everett.seay@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05050383 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05050383 clinical trial?
NCT05050383 is sponsored by University of Pennsylvania. The principal investigator is Raj C Dedhia, MD, MSCR at University of Pennsylvania. The trial plans to enroll 241 participants.