Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

NCT07003854 | Completed

• 1 other identifier: Serial 901
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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?

Conditions

Obstructive Sleep Apnea

Keywords

Mandibular advancing device

Outcome Measures

Primary Outcomes (1)

• change in AHI

  difference between pre-tretment and post-treatment Apnea Hypopnea Index

  frpm enrollment to assessment of outcomes at least 8weeks

Study Arms (1)

mild-moderate obstructive sleep apnea subjects

EXPERIMENTAL

receiving mandibular advancing devices

Device: Mandibular advancement device

Interventions

Mandibular advancement device DEVICE

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

mild-moderate obstructive sleep apnea subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry AinShams University

Cairo, Abbaseya, 11766, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Rania Mohamed Magdy, lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 4, 2025
• Study Start: January 15, 2022
• Primary Completion: October 15, 2024
• Study Completion: January 15, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After one year of publication of results
• Access Criteria: Anyone can access Polysomnographic data through personal communication

Locations

EG (1)