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) .
Is the treatment Drug-induced sleep endoscopy (DISE) a promising treatment for obstructive sleep apnea?Yes, Drug-induced sleep endoscopy (DISE) is a promising treatment for obstructive sleep apnea because it allows doctors to see the airway directly and understand where and how it collapses during sleep. This helps in planning effective treatments. DISE is also safe, cost-effective, and can be easily used in clinical practice.14567
What data supports the idea that DISE Phenotyping for Obstructive Sleep Apnea is an effective treatment?The available research shows that DISE Phenotyping for Obstructive Sleep Apnea helps in customizing surgical plans, which can lead to better surgical outcomes. It allows doctors to see exactly where the airway is blocked, making surgeries more successful. Additionally, DISE-PAP is described as an affordable and efficient method to assess airway collapsibility, which can help in planning effective treatments. While the studies do not directly compare DISE to other treatments, they highlight its role in improving surgical approaches and evaluating airway issues.13678
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data is available for DISE in treating obstructive sleep apnea?The available research indicates that drug-induced sleep endoscopy (DISE) is considered a safe and reliable tool for evaluating obstructive sleep apnea (OSA). It allows for direct observation of the airway and is used to assess airway collapse and obstruction patterns. Studies have compared different sedation regimens for DISE, focusing on their safety profiles and efficacy. DISE is described as cost-effective and safe, with its implementation in clinical practice being affordable and efficient. The procedure is performed in outpatient settings, often with sedation administered by a nurse anesthetist, and is considered safe enough to be conducted by ENT residents under supervision.12567
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 speak English and can give informed consent.
I am referred for or scheduled to have a DISE procedure.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Drug-Induced Sleep EndoscopyExperimental Treatment2 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 nearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
References
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.
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.
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.
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.
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.
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.
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.
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.