DISE: Phenotyping Obstruction Patterns

NCT05050383 | Recruiting

• 1 other identifier: 849542
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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

Keywords

sleep apnea; drug-induced sleep endoscopy; snoring

Outcome Measures

Primary Outcomes (1)

• 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

  Change in pre-operative to post-operative AHI

  Within 1 year of enrollment

Secondary Outcomes (4)

• Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE

  Within 3 months of enrollment

• Complement videoendoscopic DISE findings with synchronous ultrasound imaging

  Within 3 months of enrollment

• Compare positive airway pressure levels obtained from natural sleep to those during DISE

  Within 3 months of enrollment

• Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)

  Within 1 year of enrollment

Study Arms (1)

Drug-Induced Sleep Endoscopy

OTHER

Drug-Induced Sleep Endoscopy

Other: Pharyngeal Manometry; Other: Submental Ultrasound

Interventions

Pharyngeal Manometry OTHER

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

Drug-Induced Sleep Endoscopy

Submental Ultrasound OTHER

Ultrasound of airway soft tissues

Drug-Induced Sleep Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18yrs) willing and capable of providing informed consent.
• English-speaking \& able to give Informed Consent.
• Referred or scheduled for clinically indicated DISE procedure.
• Seeking CPAP alternatives for treatment of sleep disordered breathing.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raj C Dedhia, MD, MSCR

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Everett Seay

CONTACT

2156158777; everett.seay@pennmedicine.upenn.edu

Erica Kent

CONTACT

2156158777; erica.kent1@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Sleep Surgery

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)