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

Inspire Medical Systems

Status and phase

Completed

Phase 4

Conditions

Obstructive Sleep Apnea

Treatments

Device: Inspire® Upper Airway Stimulation (UAS) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02293746

2014-002

Details and patient eligibility

About

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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