DISE: Phenotyping Obstruction Patterns

Obstructive Sleep Apnea Clinical Trial

— DISE-PhOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050383
• Other study ID #: 849542
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: September 2027

Study information

• Verified date: April 2023
• Source: University of Pennsylvania
• Contact: Everett Seay
• Phone: 2156158777
• Email: everett.seay[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 241
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Pharyngeal Manometry
Catheters will be passed into the nose and advanced to the pharynx to measure airway pressures during drug-induced sleep.
• Submental Ultrasound
Ultrasound of airway soft tissues

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complement videoendoscopic DISE findings with synchronous ultrasound imaging	Ultrasonic evaluation of dynamic tongue motion during DISE	Within 3 months of enrollment
Secondary	Compare positive airway pressure levels obtained from natural sleep to those during DISE	Therapeutic CPAP levels	Within 3 months of enrollment
Secondary	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