NCT06256640

Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)

Mandibular Advancement Device (MAD) as an Alternative Treatment Option in Pregnant Women With Obstructive Sleep Apnea (OSA)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea of Adult
• Pregnancy Related

Interventions

Type	Name	Description
DEVICE	Mandibular advancement Device	Intra oral appliances and more specifically Mandibular Advance Devices (MAD) are one of the established alternatives to treat OSA. Oral appliances and MAD are often used interchangeably but we prefer to call them MAD as it is more descriptive of its mechanism of action. MAD are placed in the mouth to temporarily advance and stabilize the lower jaw forward in order to keep the airway open during sleep.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-02-13
• Last updated: 2025-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study