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NCT Number: NCT05050383

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) .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Raj C Dedhia, MD, MSCR

CONTACT

(215) 615-8777

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

Pharyngeal Manometry

Other

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

Submental ultrasound

Other

Ultrasound of airway soft tissues

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

    Time frame: Within 1 year of enrollment

    Change in pre-operative to post-operative AHI

Secondary outcomes

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

    Time frame: Within 3 months of enrollment

    Craniofacial measurements of bones and soft tissues from CT scans

  2. Complement videoendoscopic DISE findings with synchronous ultrasound imaging

    Time frame: Within 3 months of enrollment

    Ultrasonic evaluation of dynamic tongue motion during DISE

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

    Time frame: Within 3 months of enrollment

    Therapeutic CPAP levels

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

    Time frame: Within 1 year of enrollment

    Polysomnography metrics (e.g., apnea:hypopnea ratio), questionnaire data (ESS, ISI, FOSQ-10, NOSE, Snoring VAS, etc.)

Study contacts

Contact information is provided by the study sponsor or research team.

Erica Kent

CONTACT

[email protected]

2156158777

Everett Seay

CONTACT

[email protected]

2156158777

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: DISE-PhOP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 20, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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