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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Drug Induced Sleep Endoscopy for Obstructive Sleep Apnea?

Drug-induced sleep endoscopy (DISE) helps doctors see where the airway is blocked in people with obstructive sleep apnea, which can improve the planning and success of surgery to treat the condition. ^{1 2 3 4 5}

Is drug-induced sleep endoscopy (DISE) safe for humans?

Drug-induced sleep endoscopy (DISE) is considered a safe and reliable method for evaluating patients with obstructive sleep apnea, as it allows doctors to observe the airway directly during sleep. ^{1 2 6 7 8}

How is the treatment Drug Induced Sleep Endoscopy (DISE) different from other treatments for obstructive sleep apnea?

Drug Induced Sleep Endoscopy (DISE) is unique because it allows doctors to see how the upper airway behaves during sleep, helping them tailor surgical treatments for obstructive sleep apnea more effectively. Unlike traditional methods that examine the airway while awake, DISE provides a real-time view during sleep, which can lead to better treatment decisions, especially for those who can't use standard therapies like CPAP (continuous positive airway pressure). ^{2 4 9 10 11}

Research Team

Jason Yu, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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 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]

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 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]

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 (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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison of three sedation regimens for drug-induced sleep endoscopy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preoperative Drug Induced Sleep Endoscopy Improves the Surgical Approach to Treatment of Obstructive Sleep Apnea. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

The role of drug-induced sleep endoscopy: predicting and guiding upper airway surgery for adult OSA patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Awake examination versus DISE for surgical decision making in patients with OSA: A systematic review. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy as a Selection Tool for Surgical Management of Obstructive Sleep Apnoea Syndrome: Our Personal Experience. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. [2020]

7. England 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. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

The use of drug-induced sleep endoscopy in England and Belgium. [2018]

9. United States 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A trial of drug-induced sleep endoscopy in the surgical management of sleep-disordered breathing. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy in Treatment Options Selection. [2019]