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

Last updated: January 27, 2025
Sponsor: Henry Ford Health System
Overall Status: Trial Not Available

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Mandibular advancement Device

Clinical Study ID

NCT06256640
15984-01
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Singleton pregnancy, gestational week 14-20.

  2. Age ≥ 18, English-speaking.

  3. Reliable internet access (questionnaires/surveys)

  4. Untreated mild to mild-moderate OSA defined as AHI between 5-20 events/hour on themost recent home sleep study

  5. No significant hypoxemia on the initial sleep study defined as SaO2 nadir ≥70% andSaO2 equal or less than 30 minutes ≥88%

  6. The sleep study must have been a home sleep test that uses Peripheral Arterial Tonesignal for evaluation of apneic events. The home sleep test has to be a WatchPATdevice (WatchPAT® Home Sleep Study Device | Itamar Medical Ltd.).

  7. No significant confounding comorbidities including restless leg symptoms andcircadian disorders (shift work)

  8. BMI less or equal to 40 and neck size less or equal to 40 cm

  9. Good oral health with manual dexterity and at least 8 tooth per arch

Exclusion

Exclusion Criteria:

  1. High risk pregnancy (age >40y, superimposed preeclampsia, pre-existing cardiacdisease, severe organ dysfunction such as liver or renal failure, any condition thatrequires anticoagulation), and any condition Dr. Pitts or Dr Smith deem serious riskto mother/fetus. Well controlled chronic hypertension and diabetes are allowed andwill not be excluded.

  2. Dental exclusion criteria: Complete edentulous arch, ongoing oral rehabilitation,uncontrolled periodontal disease, ongoing orthodontic treatment or completedtreatment in a period less than 5 years, temporomandibular dysfunction (active acutepain or limitations on mandibula movements of any kind), prior oropharyngealsurgery, maximum protrusion less 5 mm

  3. Significant acute health problems that are unrelated to pregnancy or dental diseasesincluding unstable psychiatric disease

  4. Non-English speaking

  5. Unable to provide informed consent

Study Design

Treatment Group(s): 1
Primary Treatment: Mandibular advancement Device
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Site Not Available

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