Recruiting NCT05050383

DISE: Phenotyping Obstruction Patterns

No phase Interventional Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pharyngeal Manometry, Submental Ultrasound.
Who it may be relevant to: Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

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

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 [Time frame: Within 1 year of enrollment]

Secondary outcome measures (4)

Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE [Time frame: Within 3 months of enrollment]
Complement videoendoscopic DISE findings with synchronous ultrasound imaging [Time frame: Within 3 months of enrollment]
Compare positive airway pressure levels obtained from natural sleep to those during DISE [Time frame: Within 3 months of enrollment]
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy) [Time frame: Within 1 year of enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

United States · 1 center

University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT05050383 · 849542

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗