Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Inspire Medical Systems

Status: Active, not recruiting

Conditions: Obstructive Sleep Apnea

Treatments: Device: Inspire therapy; Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02907398

ADHERE UAS Registry

Details and patient eligibility

About

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Full description

This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.

Enrollment: 5,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

1. Capable of giving informed consent, as required per institution
2. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion criteria

Any patient who meets any of the following criteria will not be eligible to participate in the registry

1. Has a life expectancy of less than 1 year
2. Any reason the clinician deems patient is unfit for participation in the study

Trial design

5,000 participants in 2 patient groups

ADHERE

Description:

This group will include 250 patients who have been implanted with the Inspire therapy system, enrolled in the ADHERE Registry, and are willing to complete a follow-up home sleep apnea test (HSAT).

Treatment:

Device: Inspire therapy

CONTROL

Description:

This group will include 100 patients who have been denied insurance coverage of the Inspire therapy system implant by their provider, have had no intervention (Inspire), and are willing to complete a HSAT and provide information about their OSA treatment after denial.

Treatment:

Other: No intervention