Restless Legs SyndromeDAILY-RESTNCT05695963
Ecological Momentary Assessment in Patients With Restless Legs Syndrome
A study testing Clinical assessment, auto-questionnaires and Ecological Momentary Assessment (EMA) in people with Restless Legs Syndrome, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Clinical assessment, auto-questionnaires and Ecological Momentary Assessment (EMA)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Imad Marc Antoine GHORAYEB, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
Bordeaux
Imad Marc-Antoine GHORAYEB, MD, PhD, (0)5.56.79.55.13 ext. +33, marc-antoine.ghorayeb@chu-bordeaux.fr
Olivier BRANCHARD, (0)5.57.82.06.97 ext. +33, olivier.branchard@chu-bordeaux.fr
About this study
Official title: Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST
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.
Read the 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
- Being tested
- Clinical assessment, auto-questionnaires, Ecological Momentary Assessment (EMA), activity-rest cycle
- Keywords
- Restless Legs Syndrome, Risk Factor, Ecological Momentary Assessment, Mobile Technology, Sleep, Actigraphy
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
auto-questionnairesBehavioural
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)).
Ecological Momentary Assessment (EMA)Device
4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone
activity-rest cycleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Restless Legs Syndrome | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: auto-questionnaires; Device: Ecological Momentary Assessment (EMA); Device: activity-rest cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Ecological Momentary Assessment (EMA)
This outcome measure is composite and will be established by:
- Sufficient acceptability of the EMA methodology (at least 50% of patients who are solicited to participate in the EMA study accept the invitation);
- Low loss of EMA materials (less than 5% of participants lose or break the study-dedicated smartphone); and
- 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).
Measured: 14 days after baseline (Day 0)
Secondary outcomes (2)
Validity of Ecological Momentary Assessment (EMA)
This outcome measure is composite and will be established by:
- 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;
- 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
- 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.
Measured: 14 days after baseline (Day 0)
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.
Measured: Between baseline (day 0) and 14 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start15 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imad Marc Antoine GHORAYEB, MD, PhD, Principal investigator, University Hospital, BordeauxGwénaëlle CATHELINE, PhD, Study chair, Université de Bordeaux - INCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695963
- Sponsor's protocol ID
- CHUBX 2022/30
- Acronym
- DAILY-REST
- Status last verified
- Nov 2025
- First submitted
- 13 Jan 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST
- ClinicalTrials.gov ID
- NCT05695963
- Acronym / sponsor ID
- DAILY-REST / CHUBX 2022/30
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Risk Factor, Ecological Momentary Assessment, Mobile Technology, Sleep, Actigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restless Legs Syndrome | Experimental | Other: Clinical assessment, Behavioral: auto-questionnaires, Device: Ecological Momentary Assessment (EMA), Device: activity-rest cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentRLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded | Other | Restless Legs Syndrome |
| auto-questionnairesTo 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)). | Behavioural | Restless Legs Syndrome |
| Ecological Momentary Assessment (EMA)4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone | Device | Restless Legs Syndrome |
| activity-rest cycleTo 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. | Device | Restless Legs Syndrome |
Primary outcome
Feasibility of Ecological Momentary Assessment (EMA)
Time frame: 14 days after baseline (Day 0)
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).
2 secondary outcomes
Validity of Ecological Momentary Assessment (EMA)
Time frame: 14 days after baseline (Day 0)
Risk factors for RLS
Time frame: Between baseline (day 0) and 14 days after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imad Marc Antoine GHORAYEB, MD, PhD contact
Imad Marc Antoine GHORAYEB, MD, PhD principal investigator
University Hospital, Bordeaux
Gwénaëlle CATHELINE, PhD study chair
Université de Bordeaux - INCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment, auto-questionnaires and Ecological Momentary Assessment (EMA) in people with Restless Legs Syndrome, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imad Marc Antoine GHORAYEB, MD, PhD ((0)5.56.79.55.13 ext. +33, marc-antoine.ghorayeb@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Ecological Momentary Assessment (EMA) (time frame: 14 days after baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.