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DISE: Phenotyping Obstruction Patterns (DISE-PhOP)

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharyngeal Manometry
Submental Ultrasound
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring sleep apnea, drug-induced sleep endoscopy, snoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Drug-Induced Sleep Endoscopy

Arm Description

Drug-Induced Sleep Endoscopy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE
Craniofacial measurements of bones and soft tissues from CT scans
Complement videoendoscopic DISE findings with synchronous ultrasound imaging
Ultrasonic evaluation of dynamic tongue motion during DISE
Compare positive airway pressure levels obtained from natural sleep to those during DISE
Therapeutic CPAP levels
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.)

Full Information

First Posted
September 9, 2021
Last Updated
April 27, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05050383
Brief Title
DISE: Phenotyping Obstruction Patterns
Acronym
DISE-PhOP
Official Title
Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, drug-induced sleep endoscopy, snoring

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
241 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug-Induced Sleep Endoscopy
Arm Type
Other
Arm Description
Drug-Induced Sleep Endoscopy
Intervention Type
Other
Intervention Name(s)
Pharyngeal Manometry
Intervention Description
Catheters will be passed into the nose and advanced to the pharynx to measure airway pressures during drug-induced sleep.
Intervention Type
Other
Intervention Name(s)
Submental Ultrasound
Intervention Description
Ultrasound of airway soft tissues
Primary Outcome Measure Information:
Title
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
Description
Change in pre-operative to post-operative AHI
Time Frame
Within 1 year of enrollment
Secondary Outcome Measure Information:
Title
Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE
Description
Craniofacial measurements of bones and soft tissues from CT scans
Time Frame
Within 3 months of enrollment
Title
Complement videoendoscopic DISE findings with synchronous ultrasound imaging
Description
Ultrasonic evaluation of dynamic tongue motion during DISE
Time Frame
Within 3 months of enrollment
Title
Compare positive airway pressure levels obtained from natural sleep to those during DISE
Description
Therapeutic CPAP levels
Time Frame
Within 3 months of enrollment
Title
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)
Description
Polysomnography metrics (e.g., apnea:hypopnea ratio), questionnaire data (ESS, ISI, FOSQ-10, NOSE, Snoring VAS, etc.)
Time Frame
Within 1 year of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Everett Seay
Phone
2156158777
Email
everett.seay@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Troske
Phone
2156158777
Email
kendra.troske@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj C Dedhia, MD, MSCR
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj C Dedhia, MD, MSCR
Phone
215-615-8777

12. IPD Sharing Statement

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DISE: Phenotyping Obstruction Patterns

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