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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

DISE-PhOP Trial 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.Check my eligibility

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.See study design

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.

DISE-PhOP Trial 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.

Select...

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

DISE-PhOP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

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

+1 more

DISE-PhOP Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug-Induced Sleep EndoscopyExperimental Treatment2 Interventions

Drug-Induced Sleep Endoscopy

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,042 Total Patients Enrolled

Raj C Dedhia, MD, MSCRPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

Drug-induced sleep endoscopy (DISE) Clinical Trial Eligibility Overview. Trial Name: NCT05050383 — N/A

Obstructive Sleep Apnea Research Study Groups: Drug-Induced Sleep Endoscopy

Obstructive Sleep Apnea Clinical Trial 2023: Drug-induced sleep endoscopy (DISE) Highlights & Side Effects. Trial Name: NCT05050383 — N/A

Drug-induced sleep endoscopy (DISE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050383 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still accepting participants for this investigation?

"Clinicaltrials.gov does not list this particular medical trial as actively enrolling participants. It was posted on November 12th 2021 and last updated almost a year later, with no new patients being recruited since then. Nevertheless, 282 other clinical trials are open to applicants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DISE: Phenotyping Obstruction Patterns

Raj Dedhia, MD 2021. "DISE: Phenotyping Obstruction Patterns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050383.

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