Dental Device for Sleep Apnea During Pregnancy

(OBMAD Trial)

Overseen By Miriam Jaziri, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: High risk pregnancy, Dental issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special mouthpiece called a Mandibular Advancement Device (MAD) to assist pregnant women with mild-to-moderate sleep apnea, a condition where breathing stops and starts during sleep. The trial aims to evaluate the device's effectiveness and the number of women who choose to use it. Participants will report their symptoms, and researchers will measure sleep quality before, during, and after using the device. Women who may be suitable for this trial are those between 14-20 weeks pregnant with a single baby, have sleep apnea diagnosed at home, and maintain good oral health. As an unphased trial, this study offers an opportunity to contribute to research that could enhance sleep health for pregnant women.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, well-controlled chronic hypertension and diabetes are allowed, so you may not need to stop those medications.

What prior data suggests that this dental device is safe for pregnant women with sleep apnea?

Research has shown that Mandibular Advancement Devices (MADs) are generally easy to use. Studies have found that these devices can significantly reduce snoring. In one study, the time spent snoring each night decreased from about 26% at the start to just over 6% during pregnancy, suggesting the device might be safe for pregnant women.

MADs work by gently moving the lower jaw forward, helping to keep the airway open during sleep. This can reduce symptoms of sleep apnea, a condition where breathing repeatedly stops and starts. While the studies don't focus solely on pregnant women, they provide useful information about the device's safety.

Although no serious side effects have been reported, some users might experience minor issues like jaw soreness or dry mouth. Overall, the evidence suggests that MADs are a safe option for managing sleep apnea symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mandibular Advancement Device (MAD) is unique because it offers a non-invasive, mechanical solution for sleep apnea during pregnancy, unlike the standard continuous positive airway pressure (CPAP) machines that are often uncomfortable and require electricity. This device physically moves the lower jaw forward to keep the airway open, making it more comfortable and easier to use, especially during pregnancy when comfort is key. Researchers are excited about this treatment because it could provide an effective alternative that is safer for both the mother and the baby, without the need for medication or bulky equipment.

What evidence suggests that this dental device is effective for sleep apnea during pregnancy?

Studies have shown that Mandibular Advancement Devices (MADs) can improve sleep and reduce symptoms like snoring and daytime sleepiness in people with obstructive sleep apnea (OSA). These devices are often more comfortable and easier to use than other treatments, encouraging continued use. Research also indicates that MADs are effective for individuals with mild OSA, similar to the conditions studied in this trial. Although limited data exist on their use in pregnant women, the mechanism of MADs—moving the lower jaw forward to keep the airway open—suggests potential benefits during pregnancy. Overall, MADs offer a promising option for enhancing sleep in those with mild-to-moderate OSA. Participants in this trial will receive the Mandibular Advancement Device as the intervention under study. ^{1 2 4 6 7}

Who Is on the Research Team?

Miriam Jaziri, MD

Principal Investigator

Henry Ford Hospital

Are You a Good Fit for This Trial?

This trial is for pregnant women who have mild-to-moderate obstructive sleep apnea (OSA). The study aims to enroll 10 participants. Specific eligibility criteria are not provided, but typically, trials require participants to meet certain health standards and exclude those with conditions that could interfere with the study or pose a risk.

Inclusion Criteria

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

Singleton pregnancy, gestational week 14-20

Reliable internet access for questionnaires/surveys

Exclusion Criteria

High-risk pregnancy (age >40y, superimposed preeclampsia, pre-existing cardiac disease, severe organ dysfunction such as liver or renal failure, any condition deemed serious risk to mother/fetus by Dr. Pitts or Dr. Smith. Well-controlled chronic hypertension and diabetes are allowed and will not be excluded

I don't have major ongoing dental issues or recent major dental treatments.

I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Mandibular Advancement Device (MAD) for 10 weeks during pregnancy

10 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum assessment

3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Mandibular Advancement Device (MAD)

Trial Overview The trial is testing the use of a Mandibular Advancement Device (MAD) in pregnant women with OSA. It's a single-arm study, meaning all participants will receive the MAD treatment. Their symptoms and sleep quality will be monitored before, during (for 10 weeks), and after pregnancy.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Mandibular Advancement Device (MAD) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Mandibular Advancement Device for:

• Obstructive Sleep Apnea (OSA)
• Sleep-Disordered Breathing (SDB)

Approved in United States as Mandibular Advancement Device for:

• Obstructive Sleep Apnea (OSA)
• Sleep-Disordered Breathing (SDB)

Approved in Canada as Mandibular Advancement Device for:

• Obstructive Sleep Apnea (OSA)
• Sleep-Disordered Breathing (SDB)

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

In a study of 30 patients with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS), 64.3% experienced successful treatment with a mandibular advancement device (MAD), with success linked to younger age, smaller cervical circumference, and lower apnea-hypopnea index (AHI) at baseline.

Patients with nasal abnormalities had significantly lower success rates with MAD treatment, while adherence to the device was not affected by upper airway or facial skeletal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of upper airway abnormalities on the success and adherence to mandibular advancement device treatment in patients with Obstructive Sleep Apnea Syndrome. Prescinotto, R., Haddad, FL., Fukuchi, I., et al.[2022]

In a study of 30 patients with obstructive sleep apnea-hypopnea syndrome (OSAHS), the use of a mandibular advancement device (MAD) significantly reduced the Apnea-Hypopnea Index (AHI) from 22.45 to 4.63 events per hour, indicating improved breathing during sleep.

The MAD also led to a notable decrease in snoring and an increase in oxygen saturation levels, along with a significant reduction in daytime sleepiness, demonstrating its efficacy as a treatment option for OSAHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decrease of respiratory events in patients with obstructive sleep apnea-hypopnea syndrome using a mandibular advancement device assessed with split night polysomnography. García-Campos, E., Labra, A., Galicia-Polo, L., et al.[2020]

Mandibular advancement devices (MAD) are effective for treating obstructive sleep apnea (OSA), but long-term use (2 to 11 years) can lead to significant dental and skeletal side effects, such as changes in overjet, overbite, and incisor inclination.

The severity of these side effects increases with the duration of MAD therapy, highlighting the need for ongoing patient monitoring and informed consent regarding potential dental changes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental and skeletal long-term side effects of mandibular advancement devices in obstructive sleep apnea patients: a systematic review with meta-regression analysis. Bartolucci, ML., Bortolotti, F., Martina, S., et al.[2019]

In a study of 29 patients with moderate-to-severe Obstructive Sleep Apnea (OSA), the fully customizable Mandibular Advancement Device (IMYS) significantly reduced the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after three months of use.

The IMYS device also improved oxygen saturation levels, indicating its potential effectiveness as a treatment option for patients with more severe forms of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. Ciavarella, D., Campobasso, A., Cazzolla, AP., et al.[2023]

In a study of 143 patients with Obstructive Sleep Apnea (OSA), no significant correlation was found between various dental parameters and the severity of OSA or the effectiveness of Mandibular Advancement Devices (MAD) in treatment outcomes.

While the median Apnea Hypopnea Index (AHI) improved significantly after three months of MAD therapy, specific dental characteristics like overbite and maximal retrusion did show differences among OSA severity groups, but they did not predict treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do dental parameters predict severity of obstructive sleep apnea and mandibular advancement device therapy outcomes? A pilot study. Uniken Venema, JAM., Bosschieter, PFN., Hoekema, A., et al.[2023]

Mandibular advancing devices (MAD) significantly reduced snoring episodes from an average of 40.42 to 20.64 episodes per hour and improved the apnoea-hypopnoea index (AHI) from 12.78 to 6.35 events per hour in 19 patients over one month.

The treatment was well-tolerated with only mild, transient side effects reported, and most patients (16 out of 19) used the device every night, indicating high compliance with the MAD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of mandibular advancing devices in the treatment of snoring and mild to moderate obstructive sleep apnoea syndrome]. Adriana, BL., Rusu, G., Mihăescu, T.[2010]

In a 5-year follow-up study of 172 patients with obstructive sleep apnea (OSA) who were intolerant to CPAP, mandibular advancement devices (MADs) showed a treatment success rate of 52%, with varying effectiveness based on the severity of OSA: 25% for mild, 52% for moderate, and 63% for severe cases.

Despite a decline in treatment success rates over time, patient satisfaction remained high, with 96.5% wanting to continue MAD therapy and 93.3% using the device for at least 4 hours per night, indicating good adherence and no new safety concerns during long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. Vecchierini, MF., Attali, V., Collet, JM., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35829947/

Adherence and efficacy of mandibular advancement splint ... Mandibular advancement splints (MAS) have been shown to improve sleep quality, daytime sleepiness and snoring in non-pregnant women. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10670328/

A Multicenter Prospective Study on the Use of a Mandibular ... The main objective of this prospective study was the evaluation of 1 mm step titration of mandible advancement in the success of treating obstructive sleep ...

3. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1144327/full

Innovations in mandibular advancement splint therapy for ... This paper reviews these current and emerging innovations in MAS therapy and their impact upon sleep apnoea management.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70192

Comparative Efficacy of Continuous Positive Airway ... Conversely, Mandibular Advancement Devices therapy offers a less invasive alternative with better adherence, especially for patients with mild ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06169228

Mandibular Advancement Device on Sleep Quality in ... Tolerability and efficacy of treatment with a mandibular advancement device (MAD) on sleep quality in patients with Obstructive Sleep Apnea (OSA) measured by ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04474756

Comparison of Efficacy of Two Mandibular Advancement ... The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), ...

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.4858

Clinical Practice Guideline for the Treatment of Obstructive ... Effect of Mandibular Advancement through Oral Appliance Therapy on Quality of Life in Obstructive Sleep Apnea: A Scoping ReviewSharma P, Raghav P, Kalonia N and ...