G47.31
Conditions
Interventions
Group 1: The CE marked Inspire system will be used within the approved intended use.
The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life meas
during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs, and at 6 and 12 months post-implant 2-night home sleep testing will be completed. Safety data wi
Sponsors
Inspire Medical Systems, Inc
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Likely suffer moderate-to-severe OSA based on history and physical, or have an established diagnosis of OSA (= 15 AHI<65) based on a prior in-lab Polysomnography 2. Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer 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
Exclusion criteria: 1. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate 2. Have any condition or procedure that has compromised neurological control of the upper airway 3. Unable or do not have the necessary assistance to operate the patient programmer 4. Pregnant or plan to become pregnant 5. Require magnetic resonance imaging (MRI) 6. Have an implantable device that may be susceptible to unintended interaction with the Inspire system. 7. Body Mass Index (BMI) of > 35 8. Central + mixed apneas > 25% of the total apnea–hypopnea index (AHI) 9. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator 10. Has a terminal illness with life expectancy < 12 months 11. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing 12. Any other reason the investigator deems subject is unfit for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6.1 Safety Endpoint Safety of the Inspire system will be assessed via the description of all reported serious adverse events and all procedure-related or device-related non-serious adverse events. 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 adverse events will be collected in the study. 6.2 Efficacy Endpoint Frequencies and descriptive statistics will be used to describe the data gathered in this study. A statistical comparison of pre-implant baseline and follow-up data may be performed. Efficacy endpoints will evaluate changes in subjects’ quality of life (QoL) and OSA severity, including: 1. Quality of life - ESS: improvement in QoL 12 months using the ESS compared to baseline. 2. Quality of life - FOSQ: improvement in QoL 12 months using the FOSQ compared to baseline. 3. OSA Severity - ODI:Reduction in the Oxygen Desaturation Index (ODI) from pre-implant baseline to the 12-month follow-up visit. The sleep studies to collect the ODI data will use two-night home sleep testing at baseline, and at 6 and 12 months. 4. OSA Severity - AHI:Reduction in the Apnea Hypopnea Index (AHI) from pre-implant baseline to the 12-month follow-up visit. The sleep studies to collect the AHI data will use two home sleep tests at pre-implant baseline, and at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data collected for additional analysis will be assessed at therapy initiation (1 month postoperatively), therapy titration (2 months postoperatively), 6 and 12 months postoperatively and include: • Therapy usage data (internal data logger of device) • Therapy titration frequency and device programming changes (data logger of device and programming protocols of telemetric programming device) • Subject satisfaction with therapy (questionnaire) | — |
Countries
Germany
Contacts
Public ContactJoachim T. Maurer
Universitäts-HNO-Klinik Schlafmedizinisches Zentrum
Outcome results
None listed