DISE Phenotyping for Obstructive Sleep Apnea

(DISE-PhOP Trial)

Recruiting in Palo Alto (17 mi)

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}

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 European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea

🇺🇸 Approved in United States as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea
• Pre-surgical evaluation for sleep apnea interventions

🇨🇦 Approved in Canada as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania Lead Sponsor

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] Drug-induced sleep endoscopy (DISE) has been poorly explored as an examination to assess positive airway pressure (PAP) therapy in patients with obstructive sleep apnea (OSA). The present study aimed to identify by DISE possible characteristics related to low compliance with PAP therapy due to respiratory complaints.

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

Practical Implementation of Sleep Endoscopy with Positive Airway Pressure in Clinical Practice. [2022] Drug-induced sleep endoscopy with positive airway pressure (DISE-PAP) is a new technique that allows for both the visualization of upper airway collapse as well as to evaluate the degree of airway collapsibility. This DISE-PAP protocol provides an affordable and clinically efficient manner in which to immediately implement this technique in clinical practice. Laryngoscope, 132:2076-2077, 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] Drug induced sleep endoscopy (DISE) allows for preoperative evaluation of the specific site and character of upper airway obstruction in obstructive sleep apnea (OSA). We aim to assess the impact DISE has on customizing the surgical plan and evaluate its role in surgical success.

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

Comparison of three sedation regimens for drug-induced sleep endoscopy. [2021] Drug-induced sleep endoscopy (DISE) allows for direct airway observation in patients with obstructive sleep apnea. This study compared the safety profiles and efficacies of three regimens for DISE.

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] Drug-induced sleep endoscopy with positive airway pressure (DISE-PAP) evaluates the collapsibility of the upper airway. It is currently unknown if body position affects this assessment. We sought to determine whether the collapsibility of the airway may change with head of bed elevation.

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

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. [2020] Drug-induced sleep endoscopy (DISE) is a cost-effective, safe, and reliable tool to evaluate obstructive sleep apnea (OSA) patients by revealing upper airway sites, patterns, and severity of obstruction. DISE provides valuable data because reliable evaluation of the OSA airway while awake has remained elusive. Few studies (with mixed results) have analyzed the correlation between pre-operation, awake airway assessments routinely performed by anesthesia and DISE results.

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

Organization and logistics of drug-induced sleep endoscopy in a training hospital. [2018] Drug-induced sleep endoscopy (DISE) is a rapidly growing method to evaluate airway collapse in patients receiving non-CPAP therapies for sleep-disordered breathing (SDB). The growing number of DISEs has consequences for the organization of clinical protocols. In this paper we present our recent experiences with DISE, performed by an ENT resident, with sedation given by a nurse anesthetist, in an outpatient endoscopy setting, while the staff member/sleep surgeon discusses the findings and the recommended treatment proposal on the same day.

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

Drug-Induced Sleep Endoscopy: Technique, Indications, Tips and Pitfalls. [2020] Drug-induced sleep endoscopy (DISE) is a diagnostic tool to assess the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep. Although DISE appears simple and similar to awake endoscopy, there are many aspects that need to be standardized in order to obtain reliable and reproducible information. In this article, we will recommend how to reliably perform DISE, its indications, and how to obtain and interpret the information of the upper airway.