Research Study Summary
Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
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CW ID: 209246
Date Last Changed:
July 21, 2015
Clinical Trial Snapshot
- Both Male and Female
- 22 and up
- Overall Status
- Inspire Medical Systems, Inc.
- Facility Type
- Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (20≤AHI≤65) based on a prior in-lab Polysomnography
- Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant
- Age 22 or above
- Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
- Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- Willing and capable of providing informed consent
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Any condition or procedure that has compromised neurological control of the upper airway
- Patients who are unable or do not have the necessary assistance to operate the patient remote
- Patients who are pregnant or plan to become pregnant
- Patients who will require magnetic resonance imaging (MRI)
- Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system
Additional exclusions for study purposes only:
- Body Mass Index (BMI) of > 32
- Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
- Has a terminal illness with life expectancy < 12 months
- Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
- Any other reason the investigator deems subject is unfit for participation in the study
Protocol Number: 2014-001
This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.
Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.
This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.
Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up visits.
The subject population will consists of otherwise healthy men and women that are at least 21 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.
Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.
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