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DISE: Phenotyping Obstruction Patterns

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05050383
Acronym
DISE-PhOP
Enrollment
241
Registered
2021-09-20
Start date
2021-11-12
Completion date
2027-09-30
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, drug-induced sleep endoscopy, snoring

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) .

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.

Interventions

OTHERPharyngeal Manometry

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

Ultrasound of airway soft tissues

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 surgeryWithin 1 year of enrollmentChange in pre-operative to post-operative AHI

Secondary

MeasureTime frameDescription
Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISEWithin 3 months of enrollmentCraniofacial measurements of bones and soft tissues from CT scans
Complement videoendoscopic DISE findings with synchronous ultrasound imagingWithin 3 months of enrollmentUltrasonic evaluation of dynamic tongue motion during DISE
Compare positive airway pressure levels obtained from natural sleep to those during DISEWithin 3 months of enrollmentTherapeutic CPAP levels
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)Within 1 year of enrollmentPolysomnography metrics (e.g., apnea:hypopnea ratio), questionnaire data (ESS, ISI, FOSQ-10, NOSE, Snoring VAS, etc.)

Countries

United States

Contacts

Primary ContactEverett Seay
everett.seay@pennmedicine.upenn.edu2156158777
Backup ContactErica Kent
erica.kent1@pennmedicine.upenn.edu2156158777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026