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

NCT07422402 | Completed

• 1 other identifier: MD.24.05.854.R1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea; Drug induced sleep endoscopy

Outcome Measures

Primary Outcomes (1)

• the change in Apnea-Hypopnea Index (AHI) measured by polysomnography

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

  3 months

Study Arms (1)

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.

Procedure: Drug induced sleep endoscopy

Interventions

Drug induced sleep endoscopy PROCEDURE

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

Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohamed AbdElmoniem

  Lecturer of chest medicine faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer faculty of medicine

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

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

EG (1)