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Procedure

Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (MANTRA Trial)

N/A

Waitlist Available

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, defined by at least a 50% reduction in apnea-hypopnea index (AHI) to <20 (with hypopneas defined by 4% oxyhemoglobin desaturations)

Have been using HGNS therapy for at least 3 months and used HGNS for >20 hours/week during the past 4 weeks

Must not have

Women who are pregnant or planning to become pregnant

Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of each study phase (duration of 2-4 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a treatment called hypoglossal nerve stimulation to see if it can improve metabolism and reduce inflammation in patients with obstructive sleep apnea, potentially lowering their risk of medical issues related

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves turning off an existing therapy rather than administering a new one, side effects are related to the potential return of OSA symptoms like snoring, daytime fatigue, and restless sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant or planning to become pregnant.

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I do not have major heart, lung, liver, kidney diseases, neurodegenerative conditions, or a recent eating disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of each study phase (duration of 2-4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of each study phase (duration of 2-4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each study phase (duration of 2-4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Energy intake

Free living energy expenditure

Secondary study objectives

Insulin resistance

Other study objectives

Adiponectin levels

Apnea-Hypopnea Index (AHI)

E-selectin levels

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: No HGNS therapy (HGNS-off)Experimental Treatment1 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 Control1 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.

0 / 4Eligibility criteria met