Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

NCT ID: NCT07003854

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2025-01-15

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mild-moderate obstructive sleep apnea subjects

receiving mandibular advancing devices

Group Type: EXPERIMENTAL

Mandibular advancement device

Intervention Type: DEVICE

Custom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea

Interventions

Mandibular advancement device

Custom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rania Mohamed Magdy, lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Faculty of dentistry AinShams University

Cairo, Abbaseya, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Serial 901

Identifier Type: -

Identifier Source: org_study_id