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Ecological Momentary Assessment in Patients With Restless Legs Syndrome

NCT05695963 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Imad Marc Antoine GHORAYEB, MD, PhD · University Hospital, Bordeaux

  • Gwénaëlle CATHELINE, PhD · Université de Bordeaux - INCIA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695963 on ClinicalTrials.gov