NCT05695963

Ecological Momentary Assessment in Patients With Restless Legs Syndrome

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Restless Legs Syndrome is a common sensorimotor disorder that disturbs sleep and quality of life. One of the key diagnostic criteria of RLS is the complaint of an irresistible urge to move the legs. This urge to move is often triggered by unpleasant sensations; it occurs at rest, particularly late in the day or at sleep time, and is temporarily relieved with movement. The negative impact on quality of life is profound and the disease is associated with a substantial economic burden. Dopamine agonists show efficacy which is, however, moderate, and many patients do not experience full remission. Tolerance, paradoxical aggravation of RLS symptoms (dopamine-induced augmentation) and impulse control disorders are frequently seen in patients with RLS on dopamine agonists. Therefore, although medications are available, many patients either experience side effects or show treatment response fluctuations with periods of symptoms' remission/alleviation or exacerbation. Whether RLS symptom fluctuation is related to the natural history of the disease (independent of appropriate medical treatment) is presently unknown. Furthermore, it is unknown if such fluctuation may be due to the impact of health-related behaviors in the context of daily life (e.g. physical activity, sleep quality, mood, alcohol consumption, smoking, or specific food intake), although this question warrants further research as any potential association would provide important opportunities for prevention and intervention strategies. For these reasons, the investigators aim to test the feasibility, validity and clinical utility of ambulatory monitoring techniques such as Ecological Momentary Assessment (EMA) to document RLS symptoms severity and risk factors in daily life by collecting real-time data, and by using such information to reduce risk factor exposure and thus improve symptoms. Eligible participants will be given a study-dedicated smartphone to carry with them for a two-week period and will be equipped with wearable actigraph for the same period to monitor activity-rest cycle.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-01-25
• Last updated: 2025-11-20

Locations

1 site across 1 country: France