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RECRUITING
NCT05695963
NA

Ecological Momentary Assessment in Patients With Restless Legs Syndrome

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-01-15

Completion Date

2027-01

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

OTHER

Clinical assessment

RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded

BEHAVIORAL

auto-questionnaires

To evaluate sleep quality, daytime somnolence and mood disorders (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS) and Hospital Anxiety and Depression Scale (HADS)).

DEVICE

Ecological Momentary Assessment (EMA)

4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone

DEVICE

activity-rest cycle

To further investigate the mutual influence of sleep quality on RLS symptoms and mood, the activity-rest cycle will be monitored by wearable actigraph to be placed on the non-dominant wrist during a period of 13 days and 14 nights.

Locations (1)

CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte

Bordeaux, France