Superimposition of Intra-oral Scans in MAD Therapy for OSA

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT06612008
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mandibular Advancement Device — DEVICE
    MADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse.

Study Details

Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients. Goals: 1. To track dental and jaw changes in OSA patients using 3D scans. 2. To assess the impact of MAD on quality of life and cognitive function. Study Details: The aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging. Outcome: The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.

Key Dates

First listed
Sep 25, 2024
Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Stepwise titration
    Patients will receive a MAD with an individualized stepwise titration protocol. Initially, the device is set at 60% advancement of the maximum protrusion. Over the first 3 months, the advancement is adjusted incrementally (to 75% or 90%) based on subjective improvement in OSA symptoms and side effects. If side effects occur, the advancement is decreased.
  • Arm: Personalized titration
    Patients will receive a MAD set to baseline settings. Instead of following a standard titration process, personalized titration will use both objective data and subjective patient feedback to determine the optimal advancement. This approach takes into account individual factors such as the patient's oral anatomy, sleep study results, and specific symptoms. The goal is to achieve a personalized, optimal setting that maximizes symptom improvement and comfort.

Primary Outcome Measure

Dental occlusal measurements [ Time Frame: Baseline; Year 1; Year 2; Year 3 ]

Central Contacts

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