NCT05350332

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

Recruiting
NAAges 18+InterventionalBasic science
Emory University
~151 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Negative Pressure VentilatorPulmonary Function Testing (PFT)Transcutaneous Phrenic Nerve StimulationPercutaneous Phrenic Nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Expiratory Reserve Volume (ERV)
Measured over During PFT
+5 more outcomes measured
Obstructive Sleep Apnea
1 sites across 1 states
Georgia1
  • Jason Yu, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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
  • Expiratory Reserve Volume (ERV)During PFT

    ERV is the volume of extra air that can be forcefully breathed out after exhaling normally. ERV is impacted by body size and altitude and the normal range for adults is about 0.7 to 1.1 liters (L). ERV is obtained as part of the pulmonary function test.

  • Functional Residual Capacity (FRC)During PFT

    FRC is the amount of air remaining in the lungs after a normal exhalation. FRC is impacted by body size and altitude and the normal volume for adults is about 1.8 to 2.4 L. FRC is obtained during the pulmonary function test and is the sum of residual volume (RV; the volume of air remaining after maximum exhalation) and ERV.

  • Change in VOTE Collapse Patterns - Degree of ObstructionDuring clinical DISE and intervention DISE

    VOTE collapse patterns are obtained during the routine clinical DISE evaluation and during DISE with negative pressure ventilation. The VOTE classification codes degree of obstruction as 0 = no obstruction (no vibration), 1 = partial obstruction (vibration), and 2 = complete obstruction (collapse). Degree of obstruction is determined the velum, oropharynx lateral walls, tongue base, and epiglottis. The measurements obtained without and with negative pressure ventilation will be compared.

  • Change in VOTE Collapse Patterns - Configuration of ObstructionDuring clinical DISE and intervention DISE

    VOTE collapse patterns are obtained during the routine clinical DISE evaluation and during DISE with negative pressure ventilation. The VOTE classification codes configuration of obstruction for structures with a degree of obstruction greater than 0. The configuration of obstruction is categorized as anteroposterior (anterior structures moving posteriorly against pharyngeal wall), lateral (lateral structures moving towards airway center), or concentric (both anteroposterior and lateral movements). The measurements obtained without and with negative pressure ventilation will be compared.

  • Change in Critical Closing Pressure (Pcrit)During clinical DISE and intervention DISE

    Critical closing pressures are obtained during the routine clinical DISE evaluation and during DISE with negative pressure ventilation. Pcrit assessed pharyngeal collapsibility and is measured as centimeters of water (cm H2O). A Pcrit of less than -10 cm H2O indicates normal breathing. Patients with a Pcrit around -6cm H2O tend to snore but not have OSA. A Pcrit around or greater than 0 cm H2O is seen with obstructive sleep apnea.The measurements obtained without and with negative pressure ventilation will be compared.

  • Change in Pharyngeal Opening PressuresDuring clinical DISE and intervention DISE

    Pharyngeal opening pressures are obtained during the routine clinical DISE evaluation and during DISE with negative pressure ventilation. Opening pressures are obtained using a positive airway pressure (PAP) titration device. Pharyngeal opening pressures are defined as the minimally effective positive airway pressure that results in non-flow limited breathing. This is measured in cm H2O and ranges from 0 to 25 cm H2O, with 25 cm H2O being the maximum pressure the PAP machine is capable of generating. The measurements obtained without and with negative pressure ventilation will be compared.