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Mandibular Advancement Device (MAD) as an Alternative Treatment Option in Pregnant Women With Obstructive Sleep Apnea (OSA)
We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention (during pregnancy) and postpartum.
The purpose of this study is to explore MAD as an alternative treatment option for OSA in pregnant women. We are recruiting a small number of 10 healthy pregnant women with uncomplicated OSA (absence of significant cardiovascular, metabolic or neurocognitive consequences) who, after being offered CPAP as the recommended standard treatment, prefer to use a MAD over CPAP. All patients are recruited from a single center. We would like to get a first impression on the comfort level of these women with the MAD and their self-reported compliance and any improvement of symptoms with treatment. Additionally, we would like to test efficacy in controlling OSA with pregnancy progression. Finally, we would like to derive overall treatment effectiveness of the MAD in pregnant women as defined as a combination of efficacy and compliance.
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
Yes
Henry Ford Health
Detroit, Michigan, United States
Start Date
February 1, 2024
Primary Completion Date
February 1, 2025
Completion Date
February 1, 2025
Last Updated
January 29, 2025
Mandibular advancement Device
DEVICE
Lead Sponsor
Henry Ford Health System
NCT06430957
NCT06273683
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