Mandibular Advancement Device for Obstructive Sleep Apnea

(ROHMA Trial)

Overseen By Sara Kukuljan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Consciousness-altering, Insomnia, Sleep disorder

Disqualifiers: Age over 70, Nasal obstruction, Substance abuse, Unstable psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mouthpiece called a mandibular advancement device (MAD) to assist individuals with severe obstructive sleep apnea (OSA) who cannot use other treatments. OSA causes breathing to stop and start during sleep, leading to poor rest and tiredness. The trial targets those who couldn't tolerate hypoglossal nerve stimulation (HGNS). It suits individuals who have tried HGNS without success, can use a MAD, and can manage their sleep tests at home. Participants must also avoid other sleep apnea treatments during the study. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for those seeking alternatives.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use medications that affect sleep, consciousness, or alertness during the study.

What prior data suggests that this device is safe for treating obstructive sleep apnea?

Research has shown that mandibular advancement devices (MADs) are generally well-tolerated by people with obstructive sleep apnea (OSA). Studies have found that individuals often find them more comfortable than treatments like CPAP (continuous positive airway pressure), leading to better adherence, as people are more likely to use them regularly.

One study found that MADs work as effectively as CPAP in managing blood pressure for those at high risk of heart problems. This finding suggests that MADs are both effective and safe for individuals with additional health concerns.

Some users might experience minor side effects, such as jaw discomfort or increased saliva, while using a MAD. However, these issues are usually temporary and tend to improve over time.

Overall, research strongly supports the safety of MADs, making them a good option for those who cannot tolerate other treatments like CPAP. ^{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 alternative for those with obstructive sleep apnea (OSA) who haven't found success with hypoglossal nerve stimulation (HGNS) therapy. Unlike other treatments like CPAP machines, which can be bulky and uncomfortable, MADs are custom-fitted dental devices that gently reposition the jaw to keep the airway open during sleep. Researchers are excited about this device because it provides a promising option for patients seeking a simple, user-friendly solution to manage their OSA without relying on more invasive or cumbersome treatments.

What evidence suggests that the Mandibular Advancement Device is effective for obstructive sleep apnea?

Research shows that mandibular advancement devices (MADs) can help treat obstructive sleep apnea (OSA). Studies have found that MADs significantly reduce the number of sleep disruptions. In this trial, participants who have not succeeded with hypoglossal nerve stimulation (HGNS) therapy for moderate to severe OSA will receive treatment with a MAD. For individuals with severe OSA who cannot use CPAP (a common breathing device) or have not benefited from hypoglossal nerve stimulation, MADs offer a promising alternative. Long-term research indicates that MADs can decrease daytime sleepiness and improve overall sleep quality, making them a good option for those struggling with other treatments. ^{1 4 6 7 8}

Who Is on the Research Team?

Jay Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for people with severe obstructive sleep apnea who can't tolerate CPAP and haven't improved with hypoglossal nerve stimulation. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am 18 years old or older.

I can put in and take out the jaw device by myself.

Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT)

Exclusion Criteria

Unstable psychiatric disorders

I have insomnia or take medication for it.

I am over 70 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with a mandibular advancement device (MAD) for obstructive sleep apnea

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mandibular Advancement Device (MAD)

Trial Overview The study tests if a mandibular advancement device (MAD), which moves the jaw forward to open up airways, can help patients with severe OSA after other treatments like CPAP and HGNS have failed.

How Is the Trial Designed?

Group I: Mandibular Advancement Device (MAD) Experimental Treatment 1 Intervention

This study is experimental. It involves a single-intervention design where participants who have failed hypoglossal nerve stimulation (HGNS) therapy for moderate to severe obstructive sleep apnea (OSA) will be treated with a mandibular advancement device (MAD).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656912/

Mandibular advancement device use in obstructive sleep ... ORCADES study data from 6-month and 2-year follow-ups showed that use of a custom-made MAD was associated with significant reductions in the apnea-hypopnea ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1087079221001428

A systematic review on outcomes in obstructive sleep ... A mandibular advancement device (MAD) is a primary treatment option for mild to moderate OSA patients, and for severe OSA patients who cannot tolerate ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11626

Effectiveness of mandibular advancement devices in ... Prior studies have shown that a mandibular advancement device (MAD) is an effective nonsurgical treatment for obstructive sleep apnea.

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-024-05289-0

Clinical study of two mandibular advancement devices in the ... Both two MADs were effective in reducing REI and increasing lowest oxygen saturation on OSA patients, and Shark-fin MAD has better improvement ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0292832

Long-term efficacy of mandibular advancement devices in the ... The results suggested that long-term treatment of MAD can significantly reduce the Epworth sleepiness scale (ESS) by -3.99 (95%CI -5.93 to -2.04 ...

6. jacc.org jacc.org/doi/10.1016/j.jacc.2024.03.359

Mandibular Advancement vs CPAP for Obstructive Sleep ... MAD is noninferior to CPAP for reducing 24-hour mean arterial BP in participants with hypertension and increased cardiovascular risk.

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8034

Long-Term Objective Adherence to Mandibular Advancement ... This study shows that objective adherence with MAD and CPAP therapy is comparable and consistent over time. Self-reported adherence is higher with MAD than ...

8. academic.oup.com academic.oup.com/sleep/article-abstract/44/7/zsab015/6119670

Health outcomes of continuous positive airway pressure ... Health outcomes of continuous positive airway pressure versus mandibular advancement device for the treatment of severe obstructive sleep apnea: an individual ...