Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-003128
- Scottsdale/Phoenix, Arizona: 19-003128
NCT ID: NCT02907398
Sponsor Protocol Number: CLN-0021
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Olson, M.D., M.S. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Yasemin Tashman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available