RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-30
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05350332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (≥ 18 yrs) willing and capable of providing informed consent
  2. * Obstructive sleep apnea (AHI ≥ 5 events/hour)
  3. * Must be willing and able to provide informed consent to participate in the study.
  4. * Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation.
  5. * Patients are evaluated and cleared by anesthesia prior to the procedure.
  1. * No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD).
  2. * Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery
  3. * Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia)
  4. * No incapacitating disability that interferes with execution of the protocol

Contacts and Locations

Study Contact

Jason Yu, MD
CONTACT
470-763-3887
jyu40@emory.edu

Principal Investigator

Jason Yu, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States

Collaborators and Investigators

Sponsor: Emory University

  • Jason Yu, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2025-09

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea