Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Obstructive Sleep Apnea

February 18, 2026 updated by: MohamedAbdElmoniem, Mansoura University

Role of Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Patients With Obstructive Sleep Apnea Syndrome

Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.

Study Overview

Status

Completed

Detailed Description

Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.

DISE-guided management provides significant clinical and polysomnographic improvement in CPAP-intolerant OSA patients. Individualized, anatomy-based therapy enhances treatment precision and outcomes.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Al Mansurah, Egypt, 35516
        • Mohamed AbdElmoniem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • OSA confirmed by attended PSG
  • refusal of CPAP therapy.

Exclusion Criteria:

  • Central sleep apnea
  • severe systemic illness
  • significant dental disease
  • pregnancy
  • craniofacial abnormalities
  • temporomandibular joint disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea
evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.
evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography
Time Frame: 3 months
evaluate the the change in Apnea-Hypopnea Index (AHI) measured by polysomnography from baseline to 3 months following DISE-guided allocation.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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