Sleep Endoscopy for Obstructive Sleep Apnea

Recruiting at 2 trial locations

Overseen By Eric J Kezirian, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Disqualifiers: Minors, Pregnant, Prisoners, Allergies, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 1

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.

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.

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

Drug-induced sleep endoscopy (DISE) is generally considered safe for evaluating patients with obstructive sleep apnea, as studies have shown it to be a reliable tool with a focus on minimizing risks like oxygen desaturation during the procedure. ^{1 2 3 4 5}

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 uses sedative drugs like propofol to mimic natural sleep, allowing doctors to directly observe and assess the airway for obstructions during sleep. This approach helps tailor treatments more effectively by identifying the specific sites of airway collapse, unlike other treatments that may not provide such detailed anatomical insights. ^{1 4 6 7 8}

What data supports the effectiveness of the drug-induced sleep endoscopy (DISE) treatment for obstructive sleep apnea?

Research shows that drug-induced sleep endoscopy (DISE) helps doctors see the airway directly in patients with obstructive sleep apnea, which can improve surgical outcomes after soft tissue surgery for this condition. ^{1 4 9 10 11}

Who Is on the Research Team?

Eric J Kezirian, MD, MPH

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults with obstructive sleep apnea (OSA) who are considering surgery. It's not suitable for pregnant women, minors, prisoners, those unable to consent in English, or individuals allergic to propofol or its components like soybean oil and egg lecithin.

Inclusion Criteria

I have obstructive sleep apnea and am considering surgery.

Exclusion Criteria

You are pregnant.

My doctor says I shouldn't use propofol.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo drug-induced sleep endoscopy (DISE) to evaluate the upper airway

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Drug-Induced Sleep Endoscopy

Trial Overview The study is testing the use of drug-induced sleep endoscopy (DISE) with Propofol sedation to evaluate upper airway issues in OSA patients. It aims to assess the reliability of DISE and compare it with other techniques like X-rays.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

OSA Patients considering surgical treatment

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

Approved in European Union as DISE for:

• Evaluation of upper airway obstruction in obstructive sleep apnea

Approved in United States as DISE for:

• Evaluation of upper airway obstruction in obstructive sleep apnea

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Collaborator

Trials

10

Recruited

1,300+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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 97 patients with obstructive sleep apnea, a propofol infusion strategy effectively induced airway obstruction for assessment during drug-induced sleep endoscopy (DISE), achieving obstruction in an average of 236 seconds.

The median oxygen saturation during DISE (91.4%) was significantly higher than during standard sleep studies (81.0%), indicating that the propofol dosing strategy minimized oxygen desaturation while still allowing for effective evaluation of airway obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of drug-induced sleep endoscopy using a probability ramp propofol infusion system in patients with severe obstructive sleep apnea. Atkins, JH., Mandel, JE., Rosanova, G.[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]

A systematic review of 56 studies involving 8,540 participants found that various anesthetic agents, including propofol and sevoflurane, can cause airway collapse during drug-induced sleep endoscopy (DISE) for obstructive sleep apnea (OSA).

Dexmedetomidine was noted to cause less dynamic airway collapse compared to other agents and did not show dose-dependent effects, suggesting it may be a safer option for maintaining airway stability during DISE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of anesthesia and opioids on the upper airway: A systematic review. Ehsan, Z., Mahmoud, M., Shott, SR., et al.[2022]

In a study of 40 patients with obstructive sleep apnea, certain bedside airway screening tests, such as the Mallampati classification and thyromental distance, were found to significantly correlate with the level of airway obstruction observed during drug-induced sleep endoscopy (DISE).

The study demonstrated that jaw thrust maneuvers improved airway patency in 60% of patients, highlighting a potential intervention to manage airway challenges in obese patients undergoing anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of Bedside Airway Screening Tests With Airway Obstruction During Drug-Induced Sleep Endoscopy Ambekar, AA., Saksena, SG., Bapat, JS., et al.[2020]

In a study of 24 patients with obstructive sleep apnea syndrome (OSAS), drug-induced sleep endoscopy (DISE) was used to identify obstruction sites before surgery, revealing that some patients had untreated sites yet still achieved surgical success, indicating DISE's potential reliability in predicting outcomes.

The results showed that while DISE can help explain surgical failures, it also identified obstruction sites that did not require treatment, suggesting that a deeper understanding of pharyngeal dynamics and DISE technique could enhance surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are the obstruction sites visualized on drug-induced sleep endoscopy reliable? Blumen, MB., Latournerie, V., Bequignon, E., et al.[2018]

In a study of 60 adults with obstructive sleep apnea undergoing drug-induced sleep endoscopy, propofol was associated with a higher incidence of oxygen desaturation (<90%) compared to dexmedetomidine and ketofol, indicating a safer respiratory profile for the latter two sedatives.

Dexmedetomidine and ketofol not only showed better respiratory safety but also had fewer hemodynamic adverse events compared to propofol, although dexmedetomidine required a longer time to achieve sedation and had a longer recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory and hemodynamic effects of three different sedative regimens for drug induced sleep endoscopy in sleep apnea patients. A prospective randomized study. Elkalla, RS., El Mourad, MB.[2021]

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]

In a study of 40 patients with Obstructive Sleep Apnea undergoing drug-induced sleep endoscopy, dexmedetomidine was found to be a safer sedation option than propofol, particularly regarding respiratory function.

Patients sedated with dexmedetomidine showed better respiratory parameters and stability, making it a preferable choice for those at risk of hypoxia, while propofol resulted in lower oxygen saturation and respiratory rates during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of dexmedetomidine and propofol used for drug-induced sleep endoscopy in patients with obstructive sleep apnea syndrome. Kuyrukluyıldız, U., Binici, O., Onk, D., et al.[2020]

Drug-induced sleep endoscopy (DISE) is a valuable tool for identifying obstruction sites in patients with obstructive sleep apnea syndrome (OSAS), which can significantly influence surgical outcomes.

The review highlights that proper patient selection based on DISE findings is crucial for improving treatment efficacy in OSAS surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced sleep endoscopy: A new gold standard for evaluating OSAS? Part II: Results. Blumen, M., Bequignon, E., Chabolle, F.[2018]

Drug-induced sleep endoscopy is a crucial tool for evaluating patients with obstructive sleep apnea who may need surgery, helping to identify the specific areas of obstruction.

The technique has evolved since its introduction in 1991, and the review covers important aspects such as indications, contraindications, and scoring systems to ensure its effective use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the Diagnosis of Obstructive Sleep Apnea: Drug-Induced Sleep Endoscopy. Ravesloot, MJL., Benoist, L., van Maanen, P., et al.[2018]

Citations

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

Safety and efficacy of drug-induced sleep endoscopy using a probability ramp propofol infusion system in patients with severe obstructive sleep apnea. [2021]

3. 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]

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

The effects of anesthesia and opioids on the upper airway: A systematic review. [2022]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Correlation of Bedside Airway Screening Tests With Airway Obstruction During Drug-Induced Sleep Endoscopy [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Are the obstruction sites visualized on drug-induced sleep endoscopy reliable? [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Respiratory and hemodynamic effects of three different sedative regimens for drug induced sleep endoscopy in sleep apnea patients. A prospective randomized study. [2021]

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

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

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

Comparison of dexmedetomidine and propofol used for drug-induced sleep endoscopy in patients with obstructive sleep apnea syndrome. [2020]

10. France pubmed.ncbi.nlm.nih.gov

Drug-induced sleep endoscopy: A new gold standard for evaluating OSAS? Part II: Results. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in the Diagnosis of Obstructive Sleep Apnea: Drug-Induced Sleep Endoscopy. [2018]