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CompletedNo phase
Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals
Key facts
- Who runs it
- University Hospital, Antwerp
- Where
- Belgium6 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 182 people enrolled
- Started
- 22 Sept 2021
- Ended
- 24 Oct 2024
- Type of study
- Observational
- Treatments tested
- mandibular advancement device
- Record updated
- 24 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- obstructive apnea-hypopnea index ≥ 15 events/h sleep
- complete clinical pathway
Who cannot take part
- obstructive apnea-hypopnea index < 15 events/h sleep
- not dental fit
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Treatments tested
- mandibular advancement device
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Real-World Assessment of Clinical Evidence for Mandibular Advancement Treatment of Obstructive Sleep Apnea
- Record updated
- 24 February 2025