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

NCT06256640 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Adult
  • Pregnancy Related

Interventions

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.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Miriam Jaziri, MD · Henry Ford Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06256640 on ClinicalTrials.gov