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

RecruitingNAAges 18 Years - anyAllEmory University
NCT05350332 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pr

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD). * Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery * Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia) * No incapacitating disability that interferes with execution of the protocol
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What it tests

  • Negative Pressure Ventilator
  • Pulmonary Function Testing (PFT)
  • Transcutaneous Phrenic Nerve Stimulation
  • Percutaneous Phrenic Nerve Stimulation
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Where

1 site
Emory University Hospital Midtown
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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