Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT07003854
• Lead Sponsor: Ain Shams University

Brief Summary

The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:

Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?

Detailed Description

This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.

Study Timeline

• Study Start: 2022-01-15
• Primary Completion: 2024-10-15
• Study Completion: 2025-01-15
• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adults (18 years and older)
• Mild/Moderate obstructive sleep apnea
• Sufficient number of teeth( having at least one terminal molar)
• Healthy teeth and Periodontal ligament
• Good physical and mental capability helping the subjects to be able to deal with the appliance.

Exclusion Criteria

• Severe OSA,
• Central sleep apnea,
• Pregnant females
• Somatic or psychological disease, or medications for psychological conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change in AHI	frpm enrollment to assessment of outcomes at least 8weeks	difference between pre-tretment and post-treatment Apnea Hypopnea Index

Trial Locations

Locations (1)

Faculty of dentistry AinShams University; 🇪🇬 Cairo, Abbaseya, Egypt