Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea
Withdrawn before enrolling · Not applicable
Conditions studied: Sleep Apnea, Central, Heart Failure
In brief
The study objectives are to demonstrate the ease and safety of bilateral cervically implanted phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a form of hypoventilation syndrome, for which this device is FDA approved. We will also determine if the patient's quality and duration of life is improved by using the PNS to treat CSA in heart failure patients.
Key facts
- Study ID
- NCT03238937
- Run by
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- People needed
- 0
- Starts
- 2017-10-05
- Expected to finish
- 2019-04-29
- Last updated by the study team
- 2020-02-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 1. Male or female, age 18 to 80 years inclusive.
- New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode of heart failure requiring hospitalization in the past 24 months.
- Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment.
- Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of >15/hour with >50% being central apneas.
- Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.
You may not qualify if…
- Phrenic nerve palsy.
- Baseline hypoxia (oxygen saturation <90% on room air).
- On supplemental oxygen.
- Severe COPD.
- Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement.
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.
Where it is running
- SEMC — Brighton, Massachusetts, United States
Full record on ClinicalTrials.gov
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