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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Dental Device for Sleep Apnea During Pregnancy is an effective treatment?

The available research shows that the Mandibular Advancement Device (MAD) is effective in reducing episodes of sleep apnea. Studies indicate that MADs are often used as a first choice for treating obstructive sleep apnea, especially in patients with mild to moderate conditions. They are also considered a good alternative for those who cannot use other treatments like continuous positive airway pressure (CPAP). While the research primarily focuses on general sleep apnea patients, the effectiveness in reducing apnea episodes suggests potential benefits for pregnant individuals as well. ^{1 2 3 4 5}

What safety data exists for using mandibular advancement devices for sleep apnea?

Mandibular advancement devices (MAD) are commonly used to treat obstructive sleep apnea (OSA) and have been shown to be effective in reducing apnea episodes. They are recommended for mild to moderate OSA and can be an option for patients who are non-compliant with CPAP. However, there are potential long-term dental and skeletal side effects associated with their use, as indicated by systematic reviews and meta-regression analyses. ^{1 2 3 4 6}

Is the Mandibular Advancement Device (MAD) a promising treatment for sleep apnea during pregnancy?

Yes, the Mandibular Advancement Device (MAD) is a promising treatment for sleep apnea. It is effective in reducing apnea episodes and is often used as a first choice for treating obstructive sleep apnea. It can be customized to fit the patient's needs, making it a feasible option for many people. ^{1 2 3 4 7}

Research Team

Miriam Jaziri, MD

Principal Investigator

Henry Ford Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. Brazil 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. [2022]

2. England 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. [2019]

3. Germany 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. [2022]

6. Romania pubmed.ncbi.nlm.nih.gov

[The use of mandibular advancing devices in the treatment of snoring and mild to moderate obstructive sleep apnoea syndrome]. [2010]

7. England pubmed.ncbi.nlm.nih.gov

Do dental parameters predict severity of obstructive sleep apnea and mandibular advancement device therapy outcomes? A pilot study. [2023]