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

Trial details

Who runs it

Henry Ford Health System

Trial code

NCT06256640

Record updated

29 January 2025

Original description

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.Read full original descriptionShow less

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.

Inclusion: Singleton pregnancy, gestational week 14-20; Age ≥ 18, English-speaking; Reliable internet access (questionnaires/surveys); Untreated mild to mild-moderate OSA defined as AHI between 5-20 events/hour on the most recent home sleep study; No significant hypoxemia on the initial sleep study defined as SaO2 nadir ≥70% and SaO2 equal or less than 30 minutes ≥88%; The sleep study must have been a home sleep test that uses Peripheral Arterial Tone signal for evaluation of apneic events. The home sleep test has to be a WatchPAT device (WatchPAT® Home Sleep Study Device | Itamar Medical Ltd.); No significant confounding comorbidities including restless leg symptoms and circadian disorders (shift work); BMI less or equal to 40 and neck size less or equal to 40 cm; Good oral health with manual dexterity and at least 8 tooth per arch.

Exclusion: Dental exclusion criteria: Complete edentulous arch, ongoing oral rehabilitation, uncontrolled periodontal disease, ongoing orthodontic treatment or completed treatment in a period less than 5 years, temporomandibular dysfunction (active acute pain or limitations on mandibula movements of any kind), prior oropharyngeal surgery, maximum protrusion less 5 mm; Significant acute health problems that are unrelated to pregnancy or dental diseases including unstable psychiatric disease; High risk pregnancy (age >40y, superimposed preeclampsia, pre-existing cardiac disease, severe organ dysfunction such as liver or renal failure, any condition that requires anticoagulation), and any condition Dr. Pitts or Dr Smith deem serious risk to mother/fetus. Well controlled chronic hypertension and diabetes are allowed and will not be excluded; Non-English speaking; Unable to provide informed consent.

ClinicalTrials.gov NCT06256640