Evaluating the Impact of Adjunctive Multicomponent Behavioral Interventions in the Management of Restless Legs Syndrome

Overview

About this study

Our central hypothesis is that behavioral interventions can provide additional clinical benefits when combined with standard therapies and may result in substantial improvements in symptom control and quality of life. Our long-term goal is to develop a novel care delivery model in which patients with chronic RLS can benefit from behavioral interventions early in their care and within any clinical 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.

Inclusion Criteria:

  • Moderate or severe RLS.
  • Experience RLS symptoms at least 3 nights a week (despite medications) with associated insomnia.
  • Able to read and understand English.
  • Able to provide informed consent.
  • Own a smart device capable of download and use of the Fitbit application

Exclusion Criteria: 

  • Unable to wear a Fitbit device for the duration of the study.
  • Mild RLS.
  • Pregnant women.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/07/2024. Questions regarding updates should be directed to the study team contact.

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

Melissa Lipford, M.D.

Contact us for the latest status

Contact information:

Kale Daniel

(507) 266-4541

Daniel.Kale@mayo.edu

More information

Publications

Publications are currently not available