MAD vs HGNS for Obstructive Sleep Apnea

(OSANOVA Trial)

Overseen By Mohamed Jama

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Dental conditions, Chronic nasal obstruction, Alcohol use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates two treatments for people with moderate-to-severe obstructive sleep apnea (OSA) who struggle with or cannot use positive airway pressure (PAP) therapy. The trial compares a special dental device that moves the lower jaw forward, known as a mandibular advancement device (MAD), with a therapy that stimulates a nerve in the tongue to keep the airway open, called hypoglossal nerve stimulation (HGNS). Ideal participants have been diagnosed with moderate-to-severe OSA, have difficulty using PAP therapy, and are willing to try one of these alternative treatments. As an unphased trial, this study offers participants a unique opportunity to explore innovative treatments that could enhance their quality of life.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found hypoglossal nerve stimulation (HGNS) to be a safe treatment for obstructive sleep apnea (OSA). Most side effects related to the surgery required to implant the device. Patients reported feeling less sleepy, suggesting the treatment is generally well-tolerated over time.

Research shows the mandibular advancement device (MAD) is a safe alternative to continuous positive airway pressure (CPAP) for managing OSA. Studies indicate that MAD improves sleep quality and is as safe as CPAP, with many patients finding it more comfortable and easier to use.

Both treatments offer safe options for people with OSA who cannot use traditional CPAP therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for obstructive sleep apnea, which often involves positive airway pressure (PAP) therapy, Hypoglossal Nerve Stimulation (HGNS) and Mandibular Advancement Device (MAD) offer alternatives for patients who can't tolerate PAP. HGNS works by stimulating the hypoglossal nerve to keep the airway open during sleep, providing a targeted approach that can be more comfortable and less invasive than PAP. On the other hand, MAD physically repositions the lower jaw to prevent airway collapse, offering a simple, mechanical solution. Researchers are excited about these treatments because they provide effective options for individuals who struggle with or prefer not to use traditional PAP therapy.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

This trial will compare two treatments for obstructive sleep apnea (OSA): Hypoglossal Nerve Stimulation (HGNS) and Mandibular Advancement Devices (MADs). Studies have shown that HGNS effectively treats OSA, particularly for those unable to use CPAP, a common breathing machine. Research indicates that HGNS significantly reduces the number of times breathing stops or slows during sleep, by about 20 points on a specific scale, and has a high rate of continued use.

Mandibular Advancement Devices (MADs) have also proven effective for OSA. They work by moving the jaw forward to keep the airway open during sleep. Data shows that MADs can reduce breathing interruptions and improve symptoms for many OSA patients, with success rates ranging from 30% to 58%. Both treatments in this trial offer promising alternatives for those who struggle with CPAP therapy. ^{2 3 4 6 7}

Who Is on the Research Team?

Jay F Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe Obstructive Sleep Apnea (OSA) who can't or won't use PAP therapy. They must have a BMI of 40 kg/m² or less, mostly obstructive rather than central sleep apnea, and be able to complete surveys and sleep studies in English.

Inclusion Criteria

I agree to participate in the study.

I can visit the hospital site for the study when needed.

I can read, write, speak, and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mandibular Advancement Device (MAD) therapy or Hypoglossal Nerve Stimulation (HGNS) therapy

8 weeks

Regular visits for therapy adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hypoglossal Nerve Stimulation
• Mandibular Advancement Device

Trial Overview The OSANOVA study compares two alternative OSA treatments: a mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS), for patients not benefiting from standard PAP therapy. It measures sleep quality improvements and patient satisfaction.

How Is the Trial Designed?

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

This arm includes patients who will receive treatment with a mandibular advancement device, which is an accepted therapy for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.

Group II: Hypoglossal Nerve Stimulation (HGNS) therapy Active Control 1 Intervention

This arm consists of patients who will receive hypoglossal nerve stimulation therapy, another accepted treatment option for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.

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/PMC6364516/

The outcomes of hypoglossal nerve stimulation in ... HNS is a safe and effective treatment for CPAP refractory OSA. HNS is associated with high compliance and significantly improves subjective and objective ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124003019

Hypoglossal nerve stimulation for obstructive sleep apnea ... Results show that HGNS is an effective and safe treatment option. The Inspire device significantly improved, reducing the apnea-hypopnea index (AHI) by −20.14 ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2812536

Hypoglossal Nerve Stimulation and Cardiovascular ... This randomized clinical trial assesses the effect of hypoglossal nerve stimulation vs sham intervention on blood pressure, ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11822

Bilateral hypoglossal nerve stimulation for obstructive sleep ... This pivotal clinical trial of HNSBL demonstrated an acceptable safety profile with clinically significant improvements in obstructive sleep apnea severity and ...

5. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=38528

LCD - Hypoglossal Nerve Stimulation for the Treatment of ... Conclusions from the 5-year outcomes were that UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39124549/

Adverse Events with Hypoglossal Nerve Stimulation in the ... In this systematic review, HNS therapy for treatment of OSA is associated with a positive patient safety profile. AEs occur mainly at device implantation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07049744

Hypoglossal Nerve Stimulation for the Treatment of Adult ... The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have ...