remedē System Therapy Study

Overview

About this study

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

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.

Eligibility Criteria:

  • Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.
  • Age 18 years or older.
  • Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent.
  • In the opinion of the investigator, subject is willing and able to comply with the protocol.
  • Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
  • In the opinion of the Investigator, life expectancy exceeds one year.
  • The subject is not pregnant or planning to become pregnant.

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

Timothy Morgenthaler, M.D.

Open for enrollment

Contact information:

Brandon Clapp

(507) 284-2122

Clapp.Brandon@mayo.edu

More information

Publications

Publications are currently not available