Ecological Momentary Assessment in Patients With Restless Legs Syndrome

NCT05695963 | Recruiting

• 1 other identifier: CHUBX 2022/30
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Restless Legs Syndrome; Risk Factor; Ecological Momentary Assessment; Mobile Technology; Sleep; Actigraphy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Ecological Momentary Assessment (EMA)

  This outcome measure is composite and will be established by: 1. Sufficient acceptability of the EMA methodology (at least 50% of patients who are solicited to participate in the EMA study accept the invitation); 2. Low loss of EMA materials (less than 5% of participants lose or break the study-dedicated smartphone); and 3. High compliance rate in the completion of daily assessments (participants completing the EMA phase of the study respond to at least half of all programmed assessments, i.e. on average 50% of the total 56 sessions).

  14 days after baseline (Day 0)

Secondary Outcomes (2)

• Validity of Ecological Momentary Assessment (EMA)

  14 days after baseline (Day 0)

• Risk factors for RLS

  Between baseline (day 0) and 14 days after baseline

Study Arms (1)

Restless Legs Syndrome

EXPERIMENTAL

Other: Clinical assessment; Behavioral: auto-questionnaires; Device: Ecological Momentary Assessment (EMA); Device: activity-rest cycle

Interventions

Clinical assessment OTHER

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

Restless Legs Syndrome

auto-questionnaires BEHAVIORAL

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)).

Restless Legs Syndrome

Ecological Momentary Assessment (EMA) DEVICE

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

Restless Legs Syndrome

activity-rest cycle DEVICE

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.

Restless Legs Syndrome

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, attention-deficit/hyperactivity disorder ...) or mood disorder
• History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes
• Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure/hemodialysis, pregnancy)
• Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation
• Pregnant or breastfeeding woman
• Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

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

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Imad Marc Antoine GHORAYEB, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Gwénaëlle CATHELINE, PhD

  Université de Bordeaux - INCIA

  STUDY CHAIR

Central Study Contacts

Imad Marc Antoine GHORAYEB, MD, PhD

CONTACT

(0)5.56.79.55.13; marc-antoine.ghorayeb@chu-bordeaux.fr

Olivier BRANCHARD

CONTACT

(0)5.57.82.06.97; olivier.branchard@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)