Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
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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