What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) that involve nerve stimulation, such as hypoglossal nerve stimulation (HNS) and other electrical stimulation methods, generally have mild side effects. These can include sensations of warmth, numbness in the arm or hand, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. These side effects are similar to those observed in trials involving stimulation of the ansa cervicalis nerve for improving upper airway patency in OSA patients.

What prior FDA approvals exist?

Hypoglossal nerve stimulation (HNS) is an FDA-approved treatment for moderate to severe obstructive sleep apnea (OSA) in patients who cannot tolerate continuous positive airway pressure (CPAP). The Inspire system, a specific HNS device, has demonstrated significant improvements in OSA severity. While Ansa Cervicalis Stimulation (ACS) is still under investigation, HNS represents a similar, already approved approach to improving upper airway patency in OSA patients.

What other types of research exist?

Promising, novel alternatives to Ansa Cervicalis Stimulation (ACS) for Obstructive Sleep Apnea (OSA) patients in 2024 include Hypoglossal Nerve Stimulation (HNS), which has shown efficacy in improving upper airway patency by stimulating the hypoglossal nerve to prevent airway collapse during sleep. Additionally, advancements in oral appliance therapy and continuous positive airway pressure (CPAP) devices with improved comfort and compliance features are also noteworthy. These alternatives offer different mechanisms to address airway obstruction and have been supported by recent clinical studies.

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Neurostimulation

Nerve Stimulation for Obstructive Sleep Apnea

N/A

Recruiting

Led By David T. Kent, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.

Be older than 18 years old

Must not have

Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)

Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during dise, approximately 15 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for sleep apnea that uses electrical signals to stimulate neck muscles. It targets patients who don't respond well to standard treatments. The goal is to help keep their airways open during sleep by stretching the throat. This new approach offers an alternative for patients who have difficulty using traditional therapies.

Who is the study for?

This trial is for consenting adults with a BMI between 25 and 40, diagnosed with moderate to severe obstructive sleep apnea (OSA), characterized by an AHI of 20-80 events/hr. It's not suitable for those with neurostimulation devices, chronic opiate use, alcohol dependency, other sleep disorders, significant cardiopulmonary disease or history of upper airway surgery.

What is being tested?

The study tests the effects of ansa cervicalis stimulation (ACS) alone and combined with hypoglossal nerve stimulation (HNS) on OSA. Participants will undergo polysomnography and drug-induced sleep endoscopy to assess the impact on their upper airway during sleep.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, temporary changes in voice or swallowing due to nerve activation. There might also be risks associated with sedation required for endoscopy.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have sleep apnea with 20-80 breathing pauses per hour, mostly obstructive.

Exclusion Criteria

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

Select...

I have had surgery on my upper airway, but not for removing my tonsils.

Select...

I have another sleep disorder besides the one being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during dise, approximately 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during dise, approximately 15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and during dise, approximately 15 minutes for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Abortion, Drug-Induced

Endoscopy (procedure)

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data

+8 more

Secondary study objectives

Amount of current needed for adequate stimulation

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Muscle stimulationExperimental Treatment1 Intervention

Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and second sleep study and the Grass S88 (or comparable) muscle stimulator.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and hypoglossal nerve stimulation (HNS). CPAP works by providing a constant stream of air to keep the airway open during sleep, preventing apneas and hypopneas. Oral appliances reposition the jaw to maintain airway patency. HNS, including Ansa Cervicalis Stimulation (ACS), involves electrical stimulation of nerves controlling the muscles of the upper airway, preventing collapse without waking the patient. These mechanisms are crucial as they directly address the airway obstruction that characterizes OSA, improving sleep quality and reducing associated health risks.

[Upper Airway Stimulation in OSA].[Detection and therapy of respiratory dysfunction by implantable (cardiac) devices].