Hypoglossal Nerve Stimulation on Cardiovascular Outcomes (CARDIOSA-12)

University of Pennsylvania

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Subtherapeutic 'Sham' HGNS; Device: Therapeutic HGNS

Study type: Interventional

Funder types: Other

Identifiers

NCT03359096

834158

Details and patient eligibility

About

A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

Full description

Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans. If left untreated, it results in decreased quality of life and increased risk of heart problems. Only half of these people are able to use the main treatment, continuous positive airway pressure (CPAP) therapy, which involves wearing a mask and hose at night. A new, well-tolerated treatment - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

Enrollment: 63 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All patients recruited into the study will have already been implanted with the Inspire® HGNS device.

Additional Inclusion Criteria include:

• As tolerating the therapeutic level during sleep can take time (weeks to months), all patients must be able to use the device at the therapeutic setting (> 20 hours/week for > 1 month) prior to enrollment, based on compliance data.
• All patients will be English-speaking and able to give written informed consent.

Exclusion Criteria include:

• Inspire® remote Model 2500 or later is required. Patients with older remotes are not candidates due to limited adherence monitoring capabilities.

• Patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to HGNS implantation.

• Actively using positive airway pressure (PAP) therapy for treatment of OSA.

• Patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage.

• Pregnant women will be excluded.*

  • Women of childbearing potential must NOT be pregnant or plan on becoming pregnant. This study involves temporarily stopping treatment of obstructive sleep apnea, which may harm the fetus. If applicable, the patient will need to take a urine pregnancy test after enrollment (prior to washout #1), and again prior to washout #2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Therapeutic HGNS

Experimental group

Description:

Therapeutic Hypoglossal Nerve Stimulation (HGNS). Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study.

Treatment:

Device: Therapeutic HGNS

Subtherapeutic 'Sham' HGNS

Sham Comparator group

Description:

Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds.

Treatment:

Device: Subtherapeutic 'Sham' HGNS