Characterizing the Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Obstructive sleep apnea (AHI ≥ 5 events/hour)

• Must be willing and able to provide informed consent to participate in the study.

• Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation.

⁃ Patients are evaluated and cleared by anesthesia prior to the procedure.

Locations
United States
Georgia
Emory University Hospital Midtown
RECRUITING
Atlanta
Contact Information
Primary
Jason Yu, MD
jyu40@emory.edu
470-763-3887
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2025-09
Participants
Target number of participants: 200
Treatments
Experimental: Negative Pressure Ventilator
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).
Experimental: Transcutaneous Phrenic Nerve Stimulation
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).
Related Therapeutic Areas
Sponsors
Collaborators: Lunair Medical
Leads: Emory University

This content was sourced from clinicaltrials.gov