- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723417
DISE vs Muller's Maneuver in OSA Assessment
Role of Drug-Induced Sleep Endoscopy in Comparison to Muller's Maneuver in Obstructive Sleep Apnea Syndrome Assessment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea (OSA) is one of the most common sleep-related breathing disorders and is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, leading to intermittent hypoxia, sleep fragmentation, and significant cardiovascular and metabolic consequences. Accurate localization of the site and pattern of upper airway collapse is essential for selecting the most appropriate treatment strategy.
Müller's maneuver is a commonly used office-based endoscopic technique that evaluates upper airway collapse during forced inspiratory effort while the patient is awake. However, its diagnostic accuracy has been questioned because it does not replicate the physiological conditions of natural sleep. Drug-Induced Sleep Endoscopy (DISE) is a dynamic endoscopic examination performed under sedation, allowing direct visualization of the upper airway during a sleep-like state and providing detailed information regarding the level, degree, and configuration of airway collapse.
The present prospective study aims to compare the findings of Drug-Induced Sleep Endoscopy with those obtained by Müller's maneuver in patients diagnosed with obstructive sleep apnea. The study will evaluate the agreement between both techniques in identifying the site and pattern of upper airway obstruction and assess the potential additional diagnostic value of DISE in the preoperative assessment and treatment planning of patients with OSA. The findings of this study may help optimize patient selection for individualized therapeutic interventions and improve clinical decision-making in the management of obstructive sleep apnea.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt, 35511
- Mansoua University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years old.
- Diagnosed as OSAS according to polysomnography and AASM (June 2023).
- Body mass index < 40
Exclusion Criteria:
- Age < 18 years.
- Central sleep apnea.
- Hypoventilation syndromes.
- Cardiac arrhythmias.
- ischemic heart disease.
- Heart failure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Study Arm
Participants with obstructive sleep apnea will undergo awake flexible endoscopy with Müller's maneuver followed by Drug-Induced Sleep Endoscopy (DISE).
The findings of both procedures will be compared to assess the site, degree, and pattern of upper airway obstruction.
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Drug-induced sleep endoscopy performed under sedation to evaluate the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between Drug-Induced Sleep Endoscopy (DISE) using the VOTE cassification and Müller's Maneuver in assesment of OSA.
Time Frame: Baseline (during the same study visit)
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Agreement between Drug-Induced Sleep Endoscopy (DISE) findings, assessed using the VOTE classification, and Müller's maneuver findings in identifying the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
Agreement will be quantified using Cohen's kappa coefficient.
|
Baseline (during the same study visit)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lucy Soliman, Professor, Chest Medicine Department, Faculty of Medicine, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS.24.12.3032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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