- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422402
Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Obstructive Sleep Apnea
Role of Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Patients With Obstructive Sleep Apnea Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Al Mansurah, Egypt, 35516
- Mohamed AbdElmoniem
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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
Sponsor
Investigators
- Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD.24.05.854.R1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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