DISE Phenotyping for Obstructive Sleep Apnea

(DISE-PhOP Trial)

Overseen by Raj C Dedhia, MD, MSCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow and pressure-area relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep. The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Drug-induced sleep endoscopy (DISE) 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 surgical planning and success. DISE with positive airway pressure (DISE-PAP) is a new method that efficiently shows how much the airway collapses, helping to tailor treatments. ^{1 2 3 4 5}

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

Drug-induced sleep endoscopy (DISE) is considered safe and reliable for evaluating patients with obstructive sleep apnea, as it allows doctors to see where the airway is blocked during sleep. ^{1 2 4 6 7}

How is the treatment DISE-PAP different from other treatments for obstructive sleep apnea?

DISE-PAP is unique because it combines drug-induced sleep endoscopy (a procedure that uses medication to mimic natural sleep for airway examination) with positive airway pressure to directly observe and assess the collapsibility of the airway in real-time, which helps tailor treatment for obstructive sleep apnea more effectively than standard methods. ^{1 2 4 6 8}

Research Team

Raj C Dedhia, MD, MSCR

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who speak English and can consent to participate. It's specifically for those referred or scheduled for a DISE procedure, which examines the upper airway during sleep-like conditions, and are looking for alternatives to CPAP treatment for breathing issues during sleep.

Inclusion Criteria

I am 18 years or older and can give my consent.

I am referred for or scheduled to have a DISE procedure.

I speak English and can give informed consent.

Exclusion Criteria

Not applicable.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Drug-Induced Sleep Endoscopy (DISE)

Participants undergo DISE to evaluate upper airway obstruction using CPAP, CT, and ultrasound

3 months

Multiple visits for DISE and imaging assessments

Follow-up

Participants are monitored for outcomes associated with surgical and non-surgical treatments

12 months

Regular follow-up visits to assess treatment outcomes

Treatment Details

Interventions

• Drug-induced sleep endoscopy (DISE) (Procedure)
• Pharyngeal Manometry (Other)
• Submental Ultrasound (Other)

Trial Overview The study tests how well nasal pressure (CPAP) applied during DISE can identify functional causes of airflow blockage in sleep. It combines this with anatomic measurements from CT scans and submental ultrasound to predict success of standard surgical treatments.

Participant Groups

Group I: Drug-Induced Sleep Endoscopy Experimental Treatment 2 Interventions

Drug-Induced Sleep Endoscopy

Drug-induced sleep endoscopy (DISE) is already approved in Canada for the following indications:

Approved in Canada as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

In a study of 19 patients with obstructive sleep apnea, drug-induced sleep endoscopy (DISE) revealed that those with low compliance to positive airway pressure (PAP) therapy had significantly higher TOTAL VOTE scores, indicating more severe pharyngeal obstruction when using PAP.

The study found that a TOTAL VOTE score of 2.5 or higher during DISE with PAP was associated with a 4.6-fold increased risk of low compliance, suggesting that DISE can effectively predict which patients may struggle with PAP therapy due to airway obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can drug-induced sleep endoscopy (DISE) predict compliance with positive airway pressure therapy? A pilot study. Yui, MS., Tominaga, Q., Lopes, BCP., et al.[2022]

Drug-induced sleep endoscopy with positive airway pressure (DISE-PAP) is an innovative technique that enables doctors to visualize and assess the severity of upper airway collapse in patients.

This method is both cost-effective and efficient, making it easy to incorporate into clinical practice for better diagnosis and treatment of airway issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Implementation of Sleep Endoscopy with Positive Airway Pressure in Clinical Practice. Hutz, MJ., LoSavio, P.[2022]

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]

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 61 adults with obstructive sleep apnea, elevating the head of the bed to 30° significantly reduced airway collapsibility during drug-induced sleep endoscopy, indicating a potential benefit for patients in managing their condition.

Despite the reduction in airway collapsibility with head elevation, there was no significant change in the VOTE scoring system, suggesting that while the airway may be less collapsible, the overall assessment of airway obstruction remains consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of head of bed elevation on upper airway collapsibility during drug-induced sleep endoscopy. Owen, GS., Talati, VM., Zhang, Y., et al.[2023]

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]

Drug-induced sleep endoscopy (DISE) is becoming an important tool for assessing airway collapse in patients with sleep-disordered breathing, particularly for those not using CPAP therapies.

The study highlights a successful outpatient model where an ENT resident performs DISE with sedation managed by a nurse anesthetist, allowing for immediate discussion of findings and treatment recommendations on the same day, which could improve patient care efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization and logistics of drug-induced sleep endoscopy in a training hospital. Benoist, LB., de Vries, N.[2018]

Drug-induced sleep endoscopy (DISE) is a valuable diagnostic tool for evaluating the upper airway in patients with snoring and obstructive sleep apnea, simulating natural sleep conditions for more accurate assessments.

Standardization of the DISE procedure is crucial for obtaining reliable and reproducible results, which can enhance the interpretation of upper airway information and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy: Technique, Indications, Tips and Pitfalls. Carrasco-Llatas, M., Matarredona-Quiles, S., De Vito, A., et al.[2020]

References

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

Can drug-induced sleep endoscopy (DISE) predict compliance with positive airway pressure therapy? A pilot study. [2022]

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

Practical Implementation of Sleep Endoscopy with Positive Airway Pressure in Clinical Practice. [2022]

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

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

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

The effect of head of bed elevation on upper airway collapsibility during drug-induced sleep endoscopy. [2023]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Organization and logistics of drug-induced sleep endoscopy in a training hospital. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy: Technique, Indications, Tips and Pitfalls. [2020]