Lung Volume Techniques for Obstructive Sleep Apnea

(DISE-Pulm Trial)

Overseen By Jason Yu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Uncontrolled hypertension, Unstable angina, Heart failure, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lung volume affects throat collapse during a specific sleep-related procedure. It focuses on individuals with obstructive sleep apnea (OSA), a condition where breathing repeatedly stops during sleep, who are considering surgery as a treatment option. Participants will be divided into two groups: one using a Negative Pressure Ventilator to change lung volume and the other using neck electrodes for a similar effect. The goal is to determine if changing lung volumes can help predict or improve surgical outcomes for OSA. Individuals with OSA who are interested in surgery and have agreed to undergo Drug Induced Sleep Endoscopy (DISE) are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding OSA treatment options before surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these lung volume techniques are safe for evaluating obstructive sleep apnea?

Research has shown that both treatments in this study have been used before, with some safety information available.

Studies indicate that the negative pressure ventilator helps people with severe breathing problems. However, it can sometimes worsen sleep apnea, even in those who don't usually experience it. While generally safe, there could be issues during sleep.

Studies suggest that transcutaneous phrenic nerve stimulation, which stimulates the nerve controlling the diaphragm (the main muscle used for breathing), is safe. Long-term use in people with central sleep apnea has not shown any new safety concerns over time.

In summary, both treatments are generally safe, but each has specific concerns. Participants should discuss these with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring lung volume techniques for obstructive sleep apnea (OSA) because these methods offer a fresh approach to managing the condition. Traditional treatments for OSA, like CPAP machines and oral appliances, focus on keeping airways open mechanically. However, the new techniques under study, such as using a negative pressure ventilator and transcutaneous phrenic nerve stimulation, aim to increase lung volume in non-invasive ways. This could potentially improve breathing during sleep without the need for masks or devices worn overnight. By exploring these novel mechanisms, researchers hope to enhance treatment effectiveness and patient comfort significantly.

What evidence suggests that these lung volume techniques are effective for obstructive sleep apnea?

Research has shown that negative pressure ventilation, one of the treatments in this trial, can increase lung capacity and keep the airway open during sleep. This treatment benefits people with chronic breathing problems and may help them avoid more invasive procedures like intubation.

For transcutaneous phrenic nerve stimulation, another treatment option in this trial, studies have found it effectively reduces the number of sleep apnea episodes. This method sends electrical signals to the phrenic nerve, which controls the diaphragm and improves breathing during sleep. Both treatments in this trial aim to improve breathing issues related to obstructive sleep apnea by enhancing lung function and airflow. ^{5 6 7 8 9}

Who Is on the Research Team?

Jason Yu, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with obstructive sleep apnea interested in surgery, who are COVID-19 vaccinated or test negative. They must consent to the study and be cleared by anesthesia. Excluded are those unable to tolerate certain devices due to claustrophobia, have uncontrolled medical issues, or conditions preventing anesthesia or surgery.

Inclusion Criteria

I have been cleared by an anesthesiologist for my procedure.

You have received the COVID-19 vaccine or have a negative COVID-19 test as required by the hospital's rules.

You must be willing and able to provide informed consent to participate in the study.

Exclusion Criteria

You can't use a negative pressure ventilator or do a pulmonary function test due to feeling claustrophobic.

No incapacitating disability that interferes with execution of the protocol

I do not have any uncontrolled serious health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo drug induced sleep endoscopy (DISE) with either negative pressure ventilator or transcutaneous phrenic nerve stimulation to evaluate lung volume effects on upper airway patency.

1 day

1 visit (in-person)

Pulmonary Function Testing

Participants have a pulmonary function test to determine baseline lung volume measures.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Drug Induced Sleep Endoscopy
• Negative Pressure Ventilator
• Pulmonary Function Testing (PFT)

Trial Overview The study tests if manipulating lung volumes can prevent throat collapse during drug induced sleep endoscopy (DISE), used in surgical evaluations for OSA. One group uses a negative pressure ventilator; another has phrenic nerve stimulation. Both undergo pulmonary function testing.

How Is the Trial Designed?

Group I: Transcutaneous Phrenic Nerve Stimulation Experimental Treatment 2 Interventions

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).

Group II: Negative Pressure Ventilator Experimental Treatment 2 Interventions

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).

Drug Induced Sleep Endoscopy is already approved in United States, European Union for the following indications:

Approved in United States as Drug Induced Sleep Endoscopy for:

• Pre-surgical evaluation for obstructive sleep apnea

Approved in European Union as Drug Induced Sleep Endoscopy for:

• Pre-surgical evaluation for obstructive sleep apnea

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Lunair Medical

Industry Sponsor

Trials

3

Recruited

300+

Published Research Related to This Trial

The drug-induced sleep endoscopy with polygraphic monitoring (DISE-PG) technique is safe and feasible for evaluating patients with obstructive sleep apnea, as demonstrated in a study of 50 patients without any technical issues during the procedure.

DISE-PG is significantly more sensitive than standard drug-induced sleep endoscopy in detecting obstructive respiratory events, particularly in patients with higher apnea-hypopnea indices, which can lead to better understanding and management of upper airway dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique and Preliminary Analysis of Drug-Induced Sleep Endoscopy With Online Polygraphic Cardiorespiratory Monitoring in Patients With Obstructive Sleep Apnea Syndrome. Gobbi, R., Baiardi, S., Mondini, S., et al.[2018]

Drug-induced sleep endoscopy is a safe and effective method for assessing how the upper airway collapses during sleep, which is particularly beneficial for patients with obstructive sleep apnea who cannot tolerate CPAP therapy.

This technique helps in selecting appropriate treatment options for patients, although the lack of standardization across different sleep centers makes it challenging to compare results from various studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy in Treatment Options Selection. Chong, KB., De Vito, A., Vicini, C.[2019]

In an international survey of 298 Otolaryngologists from the UK and Belgium, it was found that drug-induced sleep endoscopy (DISE) is used significantly more in Belgium (72.9%) compared to the UK (26.1%) for patients with sleep-disordered breathing.

Belgian clinicians generally view DISE as more clinically valuable than their UK counterparts, with 54% rating it as essential, while only 16% of UK respondents found it useful, highlighting a need for improved education and consensus on DISE practices across both countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of drug-induced sleep endoscopy in England and Belgium. Veer, V., Zhang, H., Beyers, J., et al.[2018]

In a study of 85 adults with obstructive sleep apnea (OSA), drug-induced sleep endoscopy (DISE) was found to be a useful tool in predicting surgical outcomes, with 53% of patients responding positively to surgery.

Specific findings from DISE, such as complete collapse at the velum and tongue base, were associated with nonresponse, while certain anatomical features like grade 3-4 tonsillar hypertrophy were linked to better surgical outcomes, suggesting DISE can guide personalized treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of drug-induced sleep endoscopy: predicting and guiding upper airway surgery for adult OSA patients. Wang, Y., Sun, C., Cui, X., et al.[2019]

Drug-Induced Sleep Endoscopy (DISE) is a safe and effective method for assessing the specific sites and types of airway collapse in patients with obstructive sleep apnea (OSA), helping to tailor surgical interventions based on individual anatomical findings.

In a study of 30 OSA patients, DISE revealed that 40% had retropalatal collapse and 23.3% had base of tongue obstruction, leading to personalized surgical approaches that resulted in significant improvements in sleep quality and apnea episodes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy as a Selection Tool for Surgical Management of Obstructive Sleep Apnoea Syndrome: Our Personal Experience. Bharathi, MB., Rajendra Prasad, J., Satish, K.[2020]

Drug-induced sleep endoscopy (DISE) is highly effective for assessing airway collapse in patients with sleep-disordered breathing, showing more severe collapse than awake endoscopy in 38 patients, with a significant change in surgical plans for 62% of cases.

The reliability of DISE was confirmed with good agreement between blinded investigators, indicating it can be a valuable tool for surgical planning in treating sleep-disordered breathing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of drug-induced sleep endoscopy in the surgical management of sleep-disordered breathing. Gillespie, MB., Reddy, RP., White, DR., et al.[2019]

Drug-induced sleep endoscopy (DISE) significantly influences surgical decision making in patients with obstructive sleep apnea (OSA), with treatment plans changing in over 50% of cases based on DISE findings from a review of eight studies involving 535 patients.

While DISE provides valuable insights into airway obstruction during sleep, the review highlights a lack of evidence linking these changes in surgical decisions to improved surgical outcomes, indicating that further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake examination versus DISE for surgical decision making in patients with OSA: A systematic review. Certal, VF., Pratas, R., Guimarães, L., et al.[2022]

The propofol-remifentanil combination led to a significantly higher incidence of oxygen desaturation (77%) compared to the dexmedetomidine-remifentanil group (45%), indicating a safety concern with this regimen.

While the dexmedetomidine-remifentanil combination resulted in less respiratory depression, it was insufficient for adequate sedation in 50% of patients, suggesting that while it is safer, it may not be effective enough for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three sedation regimens for drug-induced sleep endoscopy. Cho, JS., Soh, S., Kim, EJ., et al.[2021]

A systematic review of 7 studies involving 791 patients found that drug-induced sleep endoscopy (DISE) did not improve surgical success rates or significantly change key outcomes like the apnea-hypopnea index (AHI) or Epworth Sleepiness Scale (ESS) scores after soft tissue surgery for obstructive sleep apnea (OSA).

The results suggest that preoperative DISE may not provide additional benefits for patients undergoing soft tissue surgery for OSA, highlighting the need for further high-quality studies to explore its potential value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is drug-induced sleep endoscopy associated with better outcomes after soft tissue surgery for sleep apnea? A systematic review and meta-analysis. Lisan, Q., Baudouin, R., Lechien, JR., et al.[2023]

In a study of 87 patients undergoing surgery for obstructive sleep apnea (OSA), those who had drug-induced sleep endoscopy (DISE) showed a significantly lower rate of multilevel surgeries (8%) compared to those who did not undergo DISE (59.5%).

Patients who underwent preoperative DISE had a much higher surgical success rate of 86%, compared to only 51.4% in those without DISE, indicating that DISE helps tailor surgical plans effectively for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Drug Induced Sleep Endoscopy Improves the Surgical Approach to Treatment of Obstructive Sleep Apnea. Huntley, C., Chou, D., Doghramji, K., et al.[2017]

Drug-induced sleep endoscopy (DISE) is a safe and effective method for evaluating obstructive sleep apnea (OSA) by identifying specific sites and patterns of airway obstruction, making it a valuable tool for treatment planning.

The study of 99 OSA patients found that common preoperative airway assessments, such as the Mallampati score and overall airway assessment, did not reliably predict patterns of airway collapse observed during DISE, reinforcing the importance of DISE as the gold standard for evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. Eggerstedt, M., Urban, MJ., Chi, E., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177095/

Effects of Negative Pressure Ventilation on Lung Volume and ... This study was designed to characterize the effects of negative extrathoracic pressure on lung volume and upper airway patency during drug-induced sleep ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC463923/

Induction of sleep apnoea with negative pressure ... Negative pressure ventilation was also associated with significant increases in the frequencies of movement arousals and changes in sleep stage. CONCLUSIONS: ...

3. aetna.com aetna.com/cpb/medical/data/200_299/0298.html

Non-invasive Negative Pressure Ventilation Several uncontrolled studies reported benefits of intermittent negative pressure ventilation in patients with chronic respiratory failure due to chest wall ...

4. publications.ersnet.org publications.ersnet.org/content/erj/20/1/187

Negative-pressure ventilation: is there still a role? These data suggest that both ventilatory techniques are equally effective in avoiding endotracheal intubation and death in COPD patients with ARF. These ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1470211824014738

New modalities for non-invasive ventilation There is now substantial evidence supporting the use of non-invasive ventilation in acute hypercpanic exacerbations of chronic respiratory failure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8441538/

A new mode of mechanical ventilation: positive + negative ... The application of this pressure for 1 hour on elderly patients suffering from severe acute respiratory failure, resulted in a significant improvement in blood ...

7. sciencedirect.com sciencedirect.com/topics/neuroscience/negative-pressure-ventilator

Negative Pressure Ventilator - an overview A negative pressure ventilator is a ventilatory mode that generates a subatmospheric pressure during inspiration, allowing the patient to breathe spontaneously.

8. atsjournals.org atsjournals.org/doi/10.1164/ajrccm.163.2.9906116

Noninvasive Ventilation | American Journal of Respiratory ... However, the tendency for negative pressure ventilators to induce obstructive sleep apnea, even in normal subjects (70), may affect safety.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6884796/

Daytime noninvasive ventilatory support for patients with ... During sleep all negative pressure body ventilators cause severe obstructive apneas [90, 91]. The biphasic chest shell ventilator (Hayek Inc ...