Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control.

The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis.

Post-implant, procedure- and device-related events, QoL questionnaires, therapy usage and device adjustment data will be collected. Sleep study data will collected during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs At 6 and 12 months post-implant, 2-night home sleep testing will be completed. Safety data will be collected throughout the study. Subjects will be exited from the study following the 12-month visits.

The subject population will consist 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 study requirements for the specified follow-up duration, 3) Met all inclusion and exclusion criteria of this protocol.

Up to 60 subjects will be implanted at up to 5 sites in Germany.

Inclusion criteria

• 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 sleep test
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer 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

Exclusion criteria

Contraindications

• Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
• Have any condition or procedure that has compromised neurological control of the upper airway
• Unable or do not have the necessary assistance to operate the patient programmer
• Pregnant or plan to become pregnant
• Require magnetic resonance imaging (MRI)
• Have 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 > 35
• Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
• 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