Clinical trial NCT06256640: Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)
Official title: Mandibular Advancement Device (MAD) as an Alternative Treatment Option in Pregnant Women With Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Pregnancy Related
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot clinical trial
Primary purpose: TREATMENT

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.

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.
2. 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
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

Primary outcomes:
measure: Describe patient uptake of MAD
timeFrame: 9 months
measure: Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA
timeFrame: 9 months
measure: Test for changes in patient-reported symptoms.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Miriam Jaziri, MD
role: PRINCIPAL_INVESTIGATOR
References: