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

NCT05350332 | Recruiting FDA Device

• 1 other identifier: STUDY00003579
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (6)

• Expiratory Reserve Volume (ERV)

  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.

  During PFT

• Functional Residual Capacity (FRC)

  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.

  During PFT

• Change in VOTE Collapse Patterns - Degree of Obstruction

  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.

  During clinical DISE and intervention DISE

• Change in VOTE Collapse Patterns - Configuration of Obstruction

  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.

  During clinical DISE and intervention DISE

• Change in Critical Closing Pressure (Pcrit)

  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.

  During clinical DISE and intervention DISE

• Change in Pharyngeal Opening Pressures

  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.

  During clinical DISE and intervention DISE

Study Arms (2)

Negative Pressure Ventilator

EXPERIMENTAL

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).

Device: Negative Pressure Ventilator; Device: Pulmonary Function Testing (PFT)

Transcutaneous Phrenic Nerve Stimulation

EXPERIMENTAL

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).

Device: Pulmonary Function Testing (PFT); Device: Transcutaneous Phrenic Nerve Stimulation

Interventions

Negative Pressure Ventilator DEVICE

The negative pressure ventilator is an off-the-shelf FDA-approved device designed to treat respiratory patients with hypoventilation syndromes. This ventilator places the torso within a fixed container that is connected to a vacuum source, which inflates the lungs by pulling a negative pressure around the chest and abdomen. After the clinically routine DISE, a negative pressure ventilator will be placed on the participant's chest to increase lung volumes and the DISE evaluation will be repeated to observe changes.

Also known as: cuirass ventilator, Hayek turtle shell, iron lung

Negative Pressure Ventilator

Pulmonary Function Testing (PFT) DEVICE

PFT is a routine standardized clinical test evaluating lung function, consisting of two parts: spirometry and body plethysmography. In spirometry, participants breathe through a mouthpiece that measures airflow and volume to determine normal and maximal volume of inspiration/expiration. Body plethysmography is performed to calculate residual lung volumes. Participants enter in an enclosed chamber where they breathe through a mouthpiece. Changes in pressure in the sealed chamber during breathing are used to calculate the volume of air that remains in the lung after expiration. A MiniBox+ device may be used. The MiniBox+ device derives total lung capacity (TLC) during tidal breathing by the analysis of gas pressures and airflows immediately preceding and immediately following airway occlusions to calculate the same measures as conventional PFT analysis.

Also known as: MiniBox+

Negative Pressure Ventilator; Transcutaneous Phrenic Nerve Stimulation

Transcutaneous Phrenic Nerve Stimulation DEVICE

Phrenic nerve stimulation (PNS) will be performed transcutaneously using a commercially available and FDA approved peripheral neurostimulator. (Digitimer DS8R Bipolar Constant Current Stimulator). The neurostimulator consists of a stimulation generating box connected to electrodes that will be placed over the skin of the neck bilaterally over both phrenic nerves where an bipolar electric current will be used to stimulate the phrenic nerve leading to diaphragm contraction.

Transcutaneous Phrenic Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Lunair Medical: collaborator

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Related Publications (16)

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  BACKGROUND

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• Chan TG, Plageman J, Yu JL. The Repeatability of Pharyngeal Opening Pressure Under Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2024 Jul;171(1):295-302. doi: 10.1002/ohn.730. Epub 2024 Apr 12.

  PMID: 38606621 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Ventilators, Negative-Pressure; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ventilators, Mechanical; Equipment and Supplies; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jason Yu, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Yu, MD

CONTACT

470-763-3887; jyu40@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: June 30, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposal should be directed to jason.lee.yu@emory.edu.

Locations

US (1)