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

NCT06256640 | Withdrawn FDA Device

• 1 other identifier: 15984-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult; Pregnancy Related

Outcome Measures

Primary Outcomes (3)

• Describe patient uptake of MAD

  MAD adherence will be determined via patient-reported sleep diaries during the first 10-weeks of MAD intervention according to the AADSM guidelines. Specifically, patients will report each morning whether they wore their MAD and to estimate how long they wore it for. Consistent with Medicare guidelines for PAP therapy, we will operationalize compliance as wearing the device for ≥4 hrs each night for 70% of nights. We will describe compliance rates.

  9 months

• Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA

  We will assess AHI before treatment (T1), after 10 weeks of MAD treatment during pregnancy (T2), and then finally three months after childbirth (T3) via home sleep tests used in our sleep clinic per standard care. We hypothesize that AHI at T2 and T3 will be significantly lower than T1. For descriptive purposes, we will report rates of OSA remission (AHI\<5) at T2 and T3 as well as rates of positive treatment response operationalized as a ≥50% reduction in AHI from T1.

  9 months

• Test for changes in patient-reported symptoms.

  OSA is associated with increased fatigue and sleepiness. We hypothesize that patients will report lower levels of fatigue and daytime sleepiness at T2 and T3 relative to T1 baseline.

  9 months

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Mandibular advancement Device

Interventions

Mandibular advancement Device 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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Significant acute health problems that are unrelated to pregnancy or dental diseases including unstable psychiatric disease
• Non-English speaking
• Unable to provide informed consent

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Miriam Jaziri, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot clinical trial

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)