Ecological Momentary Assessment in Patients With Restless Legs Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Clinical assessment
  RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
• Поведенческое 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)).
• Устройство Ecological Momentary Assessment (EMA)
  4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone
• Устройство 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.

Первичные конечные точки

• Feasibility of Ecological Momentary Assessment (EMA) [Срок оценки: 14 days after baseline (Day 0)]

Вторичные конечные точки (2)

• Validity of Ecological Momentary Assessment (EMA) [Срок оценки: 14 days after baseline (Day 0)]
• Risk factors for RLS [Срок оценки: Between baseline (day 0) and 14 days after baseline]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

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

Идентификаторы

NCT: NCT05695963 · CHUBX 2022/30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗