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

Overview

About this study

The purpose of this study is to create a registry in order to collect Inspire therapy clinical evidence in the clinical practice setting, collect additional information on the effectiveness, use and safety in the commercial setting, and 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Must be a legal adult, ≥ 22 years old.
Capable of giving informed consent, as required per institution.
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:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Michael Olson, M.D., M.S.	Closed for enrollment	Contact information: Amy Tuchscherer C.C.R.C. (507) 538-6582 Tuchscherer.Amy@mayo.edu
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Yasemin Tashman, M.D.	Closed for enrollment	Contact information: Stephen Bansberg M.D. (480) 342-2000 Bansberg.Stephen@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Olson, M.D., M.S.

Closed for enrollment

Contact information:

Amy Tuchscherer C.C.R.C.

(507) 538-6582

Tuchscherer.Amy@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Yasemin Tashman, M.D.

Closed for enrollment

Contact information:

Stephen Bansberg M.D.

(480) 342-2000

Bansberg.Stephen@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials