Effects of Mandibular Advancing Device in Obstructive Sleep Apnea ((MADs))

Ain Shams University

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Mandibular advancement device

Study type

Interventional

Funder types

Other

Identifiers

NCT07003854

Serial 901

Details and patient eligibility

About

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?

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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