Hypoglossal Nerve Stimulation on Cardiovascular Outcomes

NCT ID: NCT03359096

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2022-01-21

Brief Summary

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Therapeutic HGNS

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.

Group Type: EXPERIMENTAL

Therapeutic HGNS

Intervention Type: DEVICE

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 The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached.

Subtherapeutic 'Sham' HGNS

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.

Group Type: SHAM_COMPARATOR

Subtherapeutic 'Sham' HGNS

Intervention Type: DEVICE

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

Interventions

Therapeutic 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 The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached.

Intervention Type: DEVICE

Subtherapeutic 'Sham' HGNS

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

Intervention Type: DEVICE

Other Intervention Names

Hypoglossal Nerve Stimulation; Sham Hypoglossal Nerve Stimulation

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Raj Dedhia, MD

Associate Professor of Otorhinolaryngology: Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raj C Dedhia, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Dedhia RC, Quyyumi AA, Park J, Shah AJ, Strollo PJ, Bliwise DL. Cardiovascular endpoints for obstructive sleep apnea with twelfth cranial nerve stimulation (CARDIOSA-12): Rationale and methods. Laryngoscope. 2018 Nov;128(11):2635-2643. doi: 10.1002/lary.27284. Epub 2018 Sep 8.

Reference Type: BACKGROUND

PMID: 30194765 (View on PubMed)

Dedhia RC, Bliwise DL, Quyyumi AA, Thaler ER, Boon MS, Huntley CT, Seay EG, Tangutur A, Strollo PJ, Gurel N, Keenan BT. Hypoglossal Nerve Stimulation and Cardiovascular Outcomes for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jan 1;150(1):39-48. doi: 10.1001/jamaoto.2023.3756.

Reference Type: DERIVED

PMID: 38032624 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

834158

Identifier Type: -

Identifier Source: org_study_id