DISE: Phenotyping Obstruction Patterns (DISE-PhOP)

Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns

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) .

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Pharyngeal Manometry; Other: Submental Ultrasound

Detailed Description

Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations and arousals. Continuous positive airway pressure (CPAP) is the therapeutic mainstay for OSA, but adherence remains poor.

Currently, there exist 3 classes of surgical therapy for OSA, each addressing a specific pathologic structure: skeletal surgery (target: jaw bones), neurostimulation (target: tongue), and soft tissue (target: soft palate). Unfortunately, there is a critical knowledge gap in terms of accurately identifying a patient's underlying mechanism of obstruction; as a result, the efficacy of surgical treatment is limited.

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. In June 2020, the investigators implemented a pilot protocol (IRB # 833511) to utilize measures of airflow, pressure catheters, and ultrasound to enhance DISE exams. Over the course of 100 patients, they refined the research protocol to generate a safe, efficient, and comprehensive physiologic exam of the upper airway in the clinical setting (Dedhia et al, ORL, 2021, in press).

Upper airway pressure-flow and pressure-area relationships will be characterized during a standard-of-care DISE by stepping through a range of nasal pressure (CPAP) levels to derive functional determinants of upper airway obstruction during sleep. The investigators' preliminary work in this area has shown patients requiring lower pressures to restore airflow experience improved outcomes with neurostimulation surgery. Their overall hypothesis is that upper airway pressure-flow/area relationships can be used to predict response to all 3 major classes of sleep surgery: skeletal, neurostimulation, and soft tissue. They will address this hypothesis by characterizing upper airway pressure-flow and pressure-area relationships while utilizing objective anatomic measurements from CT and ultrasound. These findings will allow 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.

• Study Type: Interventional
• Enrollment (Estimated): 241
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Everett Seay; Phone Number: 2156158777; Email: everett.seay@pennmedicine.upenn.edu
• Study Contact Backup: Name: Erica Kent; Phone Number: 2156158777; Email: erica.kent1@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Raj C Dedhia, MD, MSCR; Phone Number: (215) 615-8777

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drug-Induced Sleep Endoscopy	Other: Pharyngeal Manometry; Catheters will be passed into the nose and advanced to the pharynx to measure airway pressures during drug-induced sleep.; Other: Submental Ultrasound; Ultrasound of airway soft tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE	Craniofacial measurements of bones and soft tissues from CT scans	Within 3 months of enrollment
Complement videoendoscopic DISE findings with synchronous ultrasound imaging	Ultrasonic evaluation of dynamic tongue motion during DISE	Within 3 months of enrollment
Compare positive airway pressure levels obtained from natural sleep to those during DISE	Therapeutic CPAP levels	Within 3 months of enrollment
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)	Polysomnography metrics (e.g., apnea:hypopnea ratio), questionnaire data (ESS, ISI, FOSQ-10, NOSE, Snoring VAS, etc.)	Within 1 year of enrollment

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Raj C Dedhia, MD, MSCR, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: snoring; sleep apnea; drug-induced sleep endoscopy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 849542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No