Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
ADHERE 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).
  • Device: Inspire therapy
    Other names:
    • ADHERE
CONTROL 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.
  • Other: No intervention
    Other names:
    • CONTROL

More Details

Status
Active, not recruiting
Sponsor
Inspire Medical Systems, Inc.

Study Contact

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.