Inspire® Post-Approval Study / Protocol Number 2014-001

Inspire Medical Systems

Status

Active, not recruiting

Conditions

Obstructive Sleep Apnea

Treatments

Device: Inspire® UAS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413970

2014-001

Details and patient eligibility

About

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Full description

This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.

Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.

This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.

Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up visits.

The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.

Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.

Enrollment

127 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
Age 22 or above
Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote 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:

Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
Any condition or procedure that has compromised neurological control of the upper airway
Patients who are unable or do not have the necessary assistance to operate the patient remote
Patients who are pregnant or plan to become pregnant
Patients who will require magnetic resonance imaging (MRI)
Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.

Additional exclusions for study purposes only:

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