Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

(MANTRA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Must not be taking: Opiates

Disqualifiers: Pregnancy, Shift work, Cardiopulmonary, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea. The study will evaluate the effect of this treatment on metabolism-related outcomes and measures of inflammation to see if it lowers patients' risk of medical problems associated with obstructive sleep apnea (OSA).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who use opiate medications regularly.

What data supports the effectiveness of the treatment Hypoglossal Nerve Stimulation Therapy for Obstructive Sleep Apnea?

Hypoglossal nerve stimulation has shown success in treating obstructive sleep apnea, with a greater than 80% success rate. Patients using this treatment not only experience symptom improvement but also prefer it over other therapies like continuous positive airway pressure therapy. ^{1 2 3 4 5}

Is hypoglossal nerve stimulation safe for humans?

Hypoglossal nerve stimulation for obstructive sleep apnea has been studied for safety, with some reports of serious adverse events during implantation, such as iatrogenic pneumothorax (a collapsed lung caused by medical intervention). However, understanding these events helps improve surgical practices to avoid future complications. ^{1 4 6 7 8}

How is hypoglossal nerve stimulation treatment different from other treatments for obstructive sleep apnea?

Hypoglossal nerve stimulation is unique because it involves a small device implanted in the body that stimulates the nerve controlling tongue movement, helping to keep the airway open during sleep. This treatment is particularly beneficial for patients who do not respond well to traditional therapies like continuous positive airway pressure (CPAP) machines. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for individuals with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. Participants should be interested in seeing if turning off their hypoglossal nerve stimulation (HGNS) therapy affects metabolism and inflammation.

Inclusion Criteria

I haven't used any treatments for sleep apnea for at least a month before my HGNS surgery.

I am over 18, speak English, and my sleep apnea improved by at least 50% after surgery.

I have been using HGNS therapy for over 3 months, at least 20 hours a week recently.

Exclusion Criteria

Inability to provide informed consent

I am pregnant or planning to become pregnant.

Shift workers, heavy machinery operators, or unable to avoid driving during the study (e.g. commercial drivers)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HGNS-off Phase

Participants will have their HGNS therapy turned off to mimic untreated OSA

2-4 weeks

Multiple visits for assessments

HGNS-on Phase

Participants will continue with their therapeutic HGNS therapy

2-4 weeks

Multiple visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hypoglossal Nerve Stimulation Therapy (Procedure)

Trial Overview The study tests the effects of not using HGNS therapy, which typically helps keep airways open during sleep for OSA patients. It aims to understand how stopping this treatment might change metabolic health and inflammation levels.

Participant Groups

Group I: No HGNS therapy (HGNS-off) Experimental Treatment 1 Intervention

HGNS therapy will be turned off by the participant for this arm of the study. This arm will mimic the participant's untreated OSA statement before they had HGNS therapy activated.

Group II: Therapeutic HGNS (HGNS-on) Active Control 1 Intervention

Prior to enrollment in this study, participants will have been implanted with and stabilized on HGNS therapy. As part of clinical care, a therapeutic voltage setting will have been confirmed via overnight sleep study. This arm of the study maintains the participants on the HGNS therapy at the a therapeutic voltage they have been using. This is a representation of the patient's baseline status.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center New York, NY

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1529

Patients Recruited

2,832,000+

Yi Cai

Lead Sponsor

Trials

1

Patients Recruited

60+

Triological Society

Collaborator

Trials

2

Patients Recruited

60+

American Academy of Sleep Medicine

Collaborator

Trials

29

Patients Recruited

3,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic pneumothorax during hypoglossal nerve stimulator implantation. Arteaga, AA., Pitts, KD., Lewis, AF.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve (Cranial Nerve XII) Stimulation. Yu, JL., Thaler, ER.[2020]

In a study of 76 patients with obstructive sleep apnea, hypoglossal nerve stimulation significantly improved sleep metrics, reducing the median apnea-hypopnea index from 30.0 to 18.6 events per hour and the Epworth Sleepiness Scale from 13.5 to 7.6 after 12 months.

Modifying stimulation parameters from 90 μsec at 33 Hz to 120 μsec at 40 Hz reduced the voltage needed for effective tongue protrusion, indicating a potential for optimizing treatment while maintaining efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impulse Configuration in Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: The Effect of Modifying Pulse Width and Frequency. Steffen, A., Jeschke, S., Soose, RJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation for obstructive sleep apnea: A review of the literature. Wray, CM., Thaler, ER.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Xiao, R., Trask, DK., Kominsky, AH.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eastwood, PR., Barnes, M., MacKay, SG., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database. Bellamkonda, N., Shiba, T., Mendelsohn, AH.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. Korotun, M., Quintero, L., Shikowitz, M., et al.[2022]

References

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

Iatrogenic pneumothorax during hypoglossal nerve stimulator implantation. [2019]

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

Hypoglossal Nerve (Cranial Nerve XII) Stimulation. [2020]

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

Impulse Configuration in Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: The Effect of Modifying Pulse Width and Frequency. [2022]

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

Hypoglossal nerve stimulation for obstructive sleep apnea: A review of the literature. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]

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

Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database. [2021]

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

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. [2022]