Status:
COMPLETED
Hypoglossal Nerve Stimulation on Cardiovascular Outcomes
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
American Heart Association
American Academy of Sleep Medicine
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
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 hos...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03359096
Start Date
December 13 2017
End Date
January 21 2022
Last Update
March 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104