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Completed

NCT Number: NCT07723417

DISE vs Muller's Maneuver in OSA Assessment

Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder caused by recurrent upper airway collapse during sleep. Accurate identification of the site and pattern of upper airway obstruction is essential for selecting the appropriate treatment. Müller's maneuver has been widely used as an office-based assessment tool; however, it has limitations in reproducing natural sleep conditions. Drug-Induced Sleep Endoscopy (DISE) allows dynamic visualization of the upper airway under sedated conditions and may provide more accurate information about the level and pattern of airway collapse. This study aims to compare the findings of DISE with Müller's maneuver in patients with obstructive sleep apnea and to evaluate the diagnostic value of both techniques in upper airway assessment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoua University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug-induced sleep endoscopy (DISE)

Procedure

Drug-induced sleep endoscopy performed under sedation to evaluate the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.

Primary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Role of Drug-Induced Sleep Endoscopy in Comparison to Muller's Maneuver in Obstructive Sleep Apnea Syndrome Assessment

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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