Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT05350332 · Emory University

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

(DISE-Pulm)

What this study is about

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.

View original scientific 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.

Interventions

DEVICE

Negative Pressure Ventilator

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.

DEVICE

Pulmonary Function Testing (PFT)

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.

DEVICE

Transcutaneous Phrenic Nerve Stimulation

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.

Primary outcome measures

Expiratory Reserve Volume (ERV)

Time frame: 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)

Time frame: 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 Obstruction

Time frame: During 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 Obstruction

Time frame: During 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)

Time frame: 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 Pressures

Time frame: During 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Atlanta, Georgia

Collaborators

Lunair Medical

Related conditions & keywords

Obstructive Sleep Apnea

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations

📊
1 of 200 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Atlanta

Georgia

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Lupus Trials by City

Browse all lupus clinical trials in these cities — not just this study.

Looking for Obstructive Sleep Apnea Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Obstructive Sleep Apnea Treatment Options in Atlanta, Georgia

If you're searching for Obstructive Sleep Apnea treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Obstructive Sleep Apnea. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Georgia
Now Enrolling
Up to 200 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Obstructive Sleep Apnea?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Obstructive Sleep Apnea

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Obstructive Sleep Apnea Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05350332. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.