Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Restless Legs Syndrome (RLS) is a sensorimotor disorder better characterized by an urge to move the legs at rest. Although treatments are available, many patients experience periods of symptoms relief and exacerbation. Whether this is due to the natural history of the disease or to health-related behaviors of daily life is presently unknown. The primary objective is to examine the feasibility of mobile technology to assess RLS symptoms severity fluctuations in daily life by collecting real-time data. The secondary objectives will be to examine the validity of this technic in the context of RLS and to use these real-time data to identify daily life risk factors for symptom onset or aggravation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patient over 18 years old and less than 70

• Any patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria

• Normal clinical examination

• Person affiliated or benefiting from a social security scheme

• Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).

Locations
Other Locations
France
CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
RECRUITING
Bordeaux
Contact Information
Primary
Imad Marc Antoine GHORAYEB, MD, PhD
marc-antoine.ghorayeb@chu-bordeaux.fr
(0)5.56.79.55.13
Backup
Olivier BRANCHARD
olivier.branchard@chu-bordeaux.fr
(0)5.57.82.06.97
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2025-09
Participants
Target number of participants: 62
Treatments
Experimental: Restless Legs Syndrome
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov