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Clinical Trials/NCT07422402
NCT07422402CompletedNot Applicable

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

Mansoura University1 site in 1 country35 target enrollmentStarted: January 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea

Experimental

evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.

Intervention: Drug induced sleep endoscopy (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MohamedAbdElmoniem

Lecturer faculty of medicine

Mansoura University

Study Sites (1)

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