Inspire® Upper Airway Stimulation (UAS) System: CE Certificate Number 562872 German Post Market Study

• Conditions: G47.31

• Registration Number: DRKS00006328
• Lead Sponsor: Inspire Medical Systems, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified