Sleep Endoscopy for Obstructive Sleep Apnea

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Eric J Kezirian, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Minors, Pregnant, Prisoners, Allergies, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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 2 3 4 5}

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 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 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 2 9 10 11}

Research Team

Eric J Kezirian, MD, MPH

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Drug-Induced Sleep Endoscopy (Other)

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.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

OSA Patients considering surgical treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Keck Medical Center of USC Los Angeles, CA

University of Southern California, Dept. of Otolaryngology-Head & Neck Surgery Los Angeles, CA

UCLA Santa Monica Medical Center Santa Monica, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Dr. Samir A.

University of Southern California

Chief Executive Officer since 2024

PhD in Molecular Biology from the University of Southern California

Dr. Chung

University of Southern California

Chief Medical Officer since 2016

MD from UC San Diego

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+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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 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]

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

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]