Obstructive Sleep Apnea Clinical Trial
— RCTOfficial title:
Inspire® Upper Airway Stimulation System: Randomized Control Trial / European Post-Market Study
Verified date | August 2016 |
Source | Inspire Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.
Status | Terminated |
Enrollment | 16 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: 1. Meet the requirements per current CE Mark labeling 2. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation 3. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires 4. Willing and capable of providing informed consent Exclusion Criteria: 1. Do not meet any contraindications per current CE Mark labeling 2. Body Mass Index (BMI) of > 35 3. Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) 4. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator 5. Has a terminal illness with life expectancy < 12 months 6. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing 7. Any other reason the investigator deems subject is unfit for participation in the study |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Antwerpen | Antwerp | |
Germany | Klinik für HNO-Heilkunde/HNO-Schlaflabor | Lübeck | |
Germany | Universitäts-HNO-Klinik Mannheim | Mannheim | |
Germany | Klinikum rechts der Isar der Technischen Universität München | München |
Lead Sponsor | Collaborator |
---|---|
Inspire Medical Systems, Inc. |
Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline OSA at 3 Months | The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study. | 3 months post-implant | No |
Secondary | Number of Reported SAEs / Procedure & Device Related AEs | Safety of the therapy will be assessed via the description of all reported SAEs and all procedure- or device-related AEs. Adverse events will be summarized by seriousness, severity, relatedness to the device and/or procedure and temporal relationship to the procedure. No formal statistical hypotheses will be tested. Only device- or procedure-related AEs will be collected in this post-market study. | 6 months post-implant | No |
Secondary | Change from Baseline OSA at 6 Months | AHI at the 6-month follow-up will be compared to the AHI at baseline in both the ACTIVE and DELAY groups. | 6 months post-implant | No |
Secondary | Change from Baseline Breathing Indices at 6 Months | Sleep disordered breathing indices at the 6-month follow-up will be compared to the breathing indices at baseline. | 6 months post-implant | No |
Secondary | Change from Baseline Quality of Life Questionnaires (QoL) | Quality of Life (QoL) questionnaires at the 6-month visit will be compared to the QoL questionnaires at baseline. | 6 months post-implant | No |
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