Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05350332

Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy

Led by Emory University · Updated on 2025-10-20

200

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

L

Lunair Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

Obstructive sleep apnea (OSA) is a disorder where a person has recurrent choking episodes during sleep. Surgery can treat OSA and drug induced sleep endoscopy (DISE) is a procedure that surgeons use to evaluate the throat while a person is sedated, mimicking sleep, to help determine if surgery might be effective. Lung volume can influence OSA severity but the relationship between lung function and throat collapse seen on DISE has not been well studied. This study aims to see if lung volume influences what is happening in the throat during DISE. Participants will be recruited from the sleep surgery clinic where they are being evaluated for surgery to treat their OSA. Participants will have a DISE that is performed as part of their routine surgical workup for treatment of OSA. Additionally, during the DISE, they will participate in one of two study groups. One group will have a negative pressure "turtle shell" ventilator placed over the participants chest during DISE to manipulate lung volumes to see if it can improve throat collapse. A second group will have electrodes placed over the neck to stimulate the phrenic nerve to contract the diaphragm to improve lung volumes to see if it can improve throat collapse. Both groups will also have a lung function test performed.The findings of this study will be important in improving pre-surgical evaluation of patients to better predict if surgery can help as well as potentially develop new surgical therapies for the treatment of OSA.

CONDITIONS

Official Title

Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older willing and able to give informed consent
  • Diagnosis of obstructive sleep apnea with apnea-hypopnea index of 5 or more events per hour
  • Willingness to participate and provide informed consent
  • Interest in surgical treatment for OSA and consented for DISE procedure as part of clinical evaluation
  • Evaluated and cleared by anesthesia prior to the procedure
Not Eligible

You will not qualify if you...

  • Presence of uncontrolled medical conditions such as uncontrolled hypertension, unstable angina, uncompensated heart failure, or COPD
  • Any medical condition preventing anesthesia or surgery
  • Inability to tolerate negative pressure ventilator or perform pulmonary function testing due to claustrophobia or other reasons
  • Presence of disabling conditions that interfere with study participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

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Research Team

J

Jason Yu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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