NCT07003854

Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Mandibular advancement device	Custom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea

Timeline

• Start date: 2022-01-15
• Primary completion: 2024-10-15
• Completion: 2025-01-15
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: Egypt