Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07003854

Acronym

(MADs)

Enrollment

Registered

2025-06-04

Start date

2022-01-15

Completion date

2025-01-15

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Mandibular advancing device

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.

Interventions

DEVICEMandibular advancement device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026