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DISE Phenotyping for Obstructive Sleep Apnea (DISE-PhOP Trial)

N/A

Recruiting

Led By Raj C Dedhia, MD, MSCR

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥ 18yrs) willing and capable of providing informed consent

English-speaking & able to give Informed Consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months of enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial will use DISE to examine the upper airway and determine if there are any obstructions in the airway that could cause problems during sleep. It will also use nasal pressure and CT/ultrasound imaging to help predict success of standard surgical interventions to correct any problems found.

Who is the study for?

This trial is for adults over 18 who speak English and can consent to participate. It's specifically for those referred or scheduled for a DISE procedure, which examines the upper airway during sleep-like conditions, and are looking for alternatives to CPAP treatment for breathing issues during sleep.

What is being tested?

The study tests how well nasal pressure (CPAP) applied during DISE can identify functional causes of airflow blockage in sleep. It combines this with anatomic measurements from CT scans and submental ultrasound to predict success of standard surgical treatments.

What are the potential side effects?

Since this trial involves diagnostic procedures like DISE, CT scans, and ultrasounds rather than medications, side effects may include discomfort from the equipment used or anxiety related to undergoing the procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and can give my consent.

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I speak English and can give informed consent.

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I am referred for or scheduled to have a DISE procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 months of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 months of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Complement videoendoscopic DISE findings with synchronous ultrasound imaging

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

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