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

NCT ID: NCT06256640

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Mandibular advancement Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 the most recent home sleep study

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

6. 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.).

7. No significant confounding comorbidities including restless leg symptoms and circadian 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 Criteria

1. 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.

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

4. Non-English speaking

5. Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriam Jaziri, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

Other Identifiers

15984-01

Identifier Type: -

Identifier Source: org_study_id