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Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals

NCT06837285 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 182

Last updated 2025-02-24

No results posted yet for this study

Summary

Study Objectives: To retrospectively study mandibular advancement treatment efficacy using apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), in a large cohort of patients, in 'real world' settings across 6 general hospitals.

Methods: Diagnosis at 6 Belgian recognised OSA sleepcenters with type-1 polysomnography. After drug-induced sleep endoscopy by Ear-Nose-Troat-specialist, patients with positive effect of mandibular protrusion on reopening the upper airway were referred. The mandibular advancement device (MAD) was fitted in 'maximal comfortable protrusion' minus 2mm. A type-3 home polygraphy with MAD followed titration.

Conditions

  • Obstructive Sleep Apnea (OSA)
  • Mandibular Advancement Device

Interventions

DEVICE

mandibular advancement device

Results of clinical trials on MADs are regularly published in the international literature but are generally very strongly controlled studies, still far away from being applied in routine daily clinical practice. The current retrospective study evaluates real-world data to determine the extent to which MAD improves both symptoms in patients with OSA. It is estimated that about 3% of newly diagnosed OSA patients are treated with MAD. In the light of new future treatment conventions, health government departments are increasingly demanding real-world data to stimulate knowledge of the relative effectiveness and value of treatments in the management of patients in routine clinical settings.

Sponsors & Collaborators

  • AZ Sint-Maarten

    collaborator UNKNOWN

  • AZ Voorkempen

    collaborator UNKNOWN

  • AZ Monica Campus Antwerpen

    collaborator UNKNOWN

  • Imelda Hospital, Bonheiden

    collaborator OTHER

  • Vitaz

    collaborator OTHER

  • Heilig Hart Ziekenhuis Lier

    collaborator UNKNOWN

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Marc J BRAEM, DDS, PhD · UZA Afd. Tandheelkunde

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2024-10-24
Completion
2024-10-24

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837285 on ClinicalTrials.gov