NCT07723417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 17, 2026

Last Update Submit

July 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Agreement between Drug-Induced Sleep Endoscopy (DISE) using the VOTE cassification and Müller's Maneuver in assesment of OSA.

    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)

Study Arms (1)

Single Study Arm

EXPERIMENTAL

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.

Procedure: Drug-Induced Sleep Endoscopy (DISE)

Interventions

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

Single Study Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old.
  • Diagnosed as OSAS according to polysomnography and AASM (June 2023).
  • Body mass index \< 40

You may not qualify if:

  • Age \< 18 years.
  • Central sleep apnea.
  • Hypoventilation syndromes.
  • Cardiac arrhythmias.
  • ischemic heart disease.
  • Heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoua University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Lucy Soliman, Professor

    Chest Medicine Department, Faculty of Medicine, Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 23, 2026

Study Start

February 12, 2025

Primary Completion

September 10, 2025

Study Completion

March 15, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations