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Lung Volume Techniques for Obstructive Sleep Apnea (DISE-Pulm Trial)

N/A

Recruiting

Led By Jason Yu, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

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

Obstructive sleep apnea (AHI ≥ 5 events/hour)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during clinical dise and intervention dise

Awards & highlights

DISE-Pulm Trial Summary

This trial will study if lung volume has an effect on sleep apnea severity by observing patients during a drug induced sleep endoscopy.

Who is the study for?

This trial is for adults over 18 with obstructive sleep apnea interested in surgery, who are COVID-19 vaccinated or test negative. They must consent to the study and be cleared by anesthesia. Excluded are those unable to tolerate certain devices due to claustrophobia, have uncontrolled medical issues, or conditions preventing anesthesia or surgery.Check my eligibility

What is being tested?

The study tests if manipulating lung volumes can prevent throat collapse during drug induced sleep endoscopy (DISE), used in surgical evaluations for OSA. One group uses a negative pressure ventilator; another has phrenic nerve stimulation. Both undergo pulmonary function testing.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the negative pressure ventilator or from transcutaneous phrenic nerve stimulation, as well as general risks associated with sedation and pulmonary function testing.

DISE-Pulm Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and can give my consent.

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I have been diagnosed with obstructive sleep apnea.

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I have been diagnosed with obstructive sleep apnea.

DISE-Pulm Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during clinical dise and intervention dise

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during clinical dise and intervention dise

This trial's timeline: 3 weeks for screening, Varies for treatment, and during clinical dise and intervention dise for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Critical Closing Pressure (Pcrit)

Change in Pharyngeal Opening Pressures

Change in VOTE Collapse Patterns - Configuration of Obstruction

+3 more

DISE-Pulm Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcutaneous Phrenic Nerve StimulationExperimental Treatment2 Interventions

Participants with obstructive sleep apnea (OSA) who are being evaluated for surgical treatment of their OSA and having a routine clinical DISE will have their lung volume increased with transcutaneous phrenic nerve stimulation. Participants will also have a pulmonary function test performed per routine clinical protocol, but for research purposes only (i.e., not part of usual care).

Group II: Negative Pressure VentilatorExperimental Treatment2 Interventions

Participants with obstructive sleep apnea (OSA) who are being evaluated for surgical treatment of their OSA and having a routine clinical DISE will have their lung volume increased with a non-invasive negative pressure ventilator. Participants will also have a pulmonary function test performed per routine clinical protocol, but for research purposes only (i.e., not part of usual care).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulmonary Function Testing (PFT)

2013

N/A

~10

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,482 Total Patients Enrolled

Jason Yu, MDPrincipal InvestigatorEmory University

Media Library

Drug Induced Sleep Endoscopy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05350332 — N/A

Obstructive Sleep Apnea Research Study Groups: Negative Pressure Ventilator, Transcutaneous Phrenic Nerve Stimulation

Obstructive Sleep Apnea Clinical Trial 2023: Drug Induced Sleep Endoscopy Highlights & Side Effects. Trial Name: NCT05350332 — N/A

Drug Induced Sleep Endoscopy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350332 — N/A

Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05350332 — N/A

Frequently Asked Questions

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

How many participants are being accepted for this medical research?

"Indeed, the clinical trial has been listed on clinicaltrials.gov since June 30th 2022 and is still actively recruiting patients. 50 participants are needed from a single site to complete the study."

Answered by AI

Are there any current vacancies in this experiment that participants can join?

"Clinicaltrials.gov has listed that this clinical trial is currently recruiting participants, with the first post dating back to June 30th 2022 and a recent update made on the same day."

Answered by AI

Who else is applying?

What state do they live in?

Georgia

What site did they apply to?

Emory University Hospital Midtown

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have sleep apnea and want surgery, but long delays and red tape in VA system.

PatientReceived 2+ prior treatments

I was diagnosed with lung fibrosis and sleep apnea. I have 2 inhalers to help with shortness of breath. I recently contacted Covid(January 2023) which caused me to experience more breathing problems. In joining this study, it is my hope that a better treatment will help me.

PatientReceived 2+ prior treatments