Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT05050383

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharyngeal Manometry

Submental Ultrasound

Study Details

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) .

Conditions

Obstructive Sleep Apnea

Study ID

NCT05050383

Start date

Nov 12, 2021

Status verified date

Jul, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

241 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Drug-Induced Sleep Endoscopy

Drug-Induced Sleep Endoscopy

Interventions

Pharyngeal Manometry

Catheters will be passed into the nose and advanced to the pharynx to measure airway pressures during drug-induced sleep.

Submental Ultrasound

Ultrasound of airway soft tissues

Primary outcome measure

  • Identify the pathogenic determinants of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flow/area relationships during DISE to predict responses to upper airway surgery [ Time Frame: Within 1 year of enrollment ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Raj C Dedhia, MD, MSCR

(215) 615-8777

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 13, 2025

Last verified

Jul, 2025

Keywords

  • sleep apnea
  • drug-induced sleep endoscopy
  • snoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-08-13.