Ecological Momentary Assessment in Patients With Restless Legs Syndrome
ConditionRestless Legs Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Clinical assessment
Other interventionRLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
auto-questionnaires
BehavioralTo 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)).
Ecological Momentary Assessment (EMA)
Device4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone
activity-rest cycle
DeviceTo 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.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Restless Legs SyndromeExperimental treatment 4 interventions
Trial outcomes
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).
Time frame
14 days after baseline (Day 0)Secondary outcomes
1
Validity of Ecological Momentary Assessment (EMA)
This outcome measure is composite and will be established by: 1. A lack of fatigue effect, operationalized by the absence of correlation between the frequency of missing data and the number of days that the individual has participated in the study; 2. Expected correlations among conceptually-associated EMA variables (i.e., internal validity: hours of sleep should be significantly correlated with energy levels; event negativity should be significantly correlated with the severity of negative affect, etc.); and 3. Significant correlations between traditional clinical measures of RLS symptoms and EMA-based measures of RLS symptoms (convergent validity). Correlations would also be sought between validated scales (PSQI, ISI, ESS and HADS) and EMA-based measures of RLS symptoms.
Time frame
14 days after baseline (Day 0)2
Risk factors for RLS
To examine if specific daily-life behaviors or experiences on any given day as assessed by EMA (activities, environments, psychological states and mood, substance use, food, sleep habits and quality) are prospectively associated with the frequency or severity of RLS symptoms later that evening/night.
Time frame
Between baseline (day 0) and 14 days after baselineSponsors and contacts
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Source ClinicalTrials.gov