An interventional study of Clinical assessment and auto-questionnaires (PSQI, ISI, ESS and HADS) in Restless Legs Syndrome, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
Restless Legs Syndrome (RLS) is a sensorimotor disorder primarily characterized by an irresistible urge to move the legs while at rest. A key hypothesis suggests that RLS symptoms are linked to abnormal brain function in processing internally generated stimuli, particularly interoception. This distorted perception of the internal bodily state leads to maladaptive behaviors, which may manifest across a wide range of medical and psychiatric disorders. Here, the investigators hypothesize that dysfunction in the insular cortex (IC) may result in a failure of behavioral adaptation, primarily expressed as an urge to move the legs and hyperarousal, even when the body and mind need rest. This project aims to assess the relationship between interoceptive abilities and diurnal fluctuations in IC functional connectivity (FC) in patients with RLS compared to healthy controls. The investigators will also examine correlations between the FC of the interoceptive network, measured in the morning and evening on the same day, using multilayer network analysis, daily fluctuations in RLS symptom severity, and objective measurements of the sleep/wake cycle, gathered through a two-week ambulatory assessment using mobile technologies such as Ecological Momentary Assessment (EMA) and actigraphy, along with scores from self-reported questionnaires. The findings may provide strong evidence to support or refute the hypothesis of interoceptive dysfunction in RLS patients.
Despite extensive research into the pathophysiology of RLS, no unified mechanism has been identified to explain the prominent clinical features of the disorder, including both sensorimotor and non-motor symptoms. One plausible hypothesis is that RLS symptoms are related to abnormal brain function in processing internally generated stimuli, particularly interoception. Distorted perceptions of the internal bodily state can lead to maladaptive behaviors, which may manifest in a wide range of medical disorders, including RLS, attention-deficit/hyperactivity disorder (ADHD), insomnia, eating disorders/obesity, fibromyalgia, and psychiatric conditions. The interoceptive abilities of RLS patients, specifically their capacity to perceive and assess their internal bodily state, have not been extensively studied, despite their potential to deepen our understanding of the sensorimotor discomfort in the legs and associated non-motor symptoms. The IntoRLS project will therefore precisely characterize the temporal variation in symptom severity and interoceptive awareness in RLS patients, alongside their sleep/wake cycle disturbances, using ambulatory assessments. This ecological assessment will be linked to time-of-day variations in intrinsic insular connectivity, assessed via functional brain imaging. At the inclusion visit, eligible participants (both patients and matched controls) will be provided with a study-dedicated smartphone for a two-week period, as well as a wearable actigraph to monitor their activity/rest cycles. Participants will complete self-reported questionnaires assessing the severity of RLS symptoms, ADHD symptoms, anxiety and depression, daytime sleepiness, and arousal predisposition. At the end of the participation period (J+14), participants will undergo functional brain imaging sessions in the morning and evening. Between the two sessions, each participant will complete the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire and perform the Heartbeat Detection Task to evaluate interoceptive accuracy.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
This study's planned enrollment of 30 is below the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Browse Restless Legs Syndrome studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
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Clinically significant
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Other: Clinical assessment · Behavioral: auto-questionnaires (PSQI, ISI, ESS and HADS) · Device: Ecological Momentary Assessment (EMA) · Device: activity-rest cycle · Behavioral: auto-questionnaires (ASRS, PSAS, APS, MAIA-2) · Device: MRI
Behavioral: auto-questionnaires (PSQI, ISI, ESS and HADS) · Device: Ecological Momentary Assessment (EMA) · Device: activity-rest cycle · Behavioral: auto-questionnaires (ASRS, PSAS, APS, MAIA-2) · Device: MRI
RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
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)).
4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone
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.
Interoceptive awareness and accuracy estimation : Adult ADHD Self-Report Scale (ASRS), Pre-Sleep Arousal Scale (PSAS), Arousal Predisposition Scale (APS) et Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Morning and evening functional brain imaging
Functional Connectivity (FC) of the anterior and posterior insular cortex (IC) measured at rest.
The investigators hypothesize that this connectivity will differ between patients and control subjects. This outcome will be assessed through the temporal fluctuation of the BOLD signal measured during the MRI examination conducted in the morning and again in the evening.
Time frame: 14 days after baseline (Day 0)
Correlations will be explored between the scores obtained by patients and those of the healthy volunteer group on the various self-assessment scales.
Score comparisons on these same scales will also be conducted between the patient group and the healthy volunteer group. The scores analyzed will be those obtained on the following scales: * International Restless Legs Syndrome Rating Scale (IRLSRS) (to assess the severity of RLS), * Insomnia Severity Index (ISI), * Adult ADHD Self-Report Scale (ASRS) (to screen for symptoms of ADHD), * Hospital Anxiety and Depression Scale (HADS) (to assess levels of depression and anxiety), * Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) (to evaluate interoceptive awareness), * Pre-Sleep Arousal Scale (PSAS) and Arousal Predisposition Scale (APS) (to measure levels of hypervigilance), * Epworth Sleepiness Scale (ESS) (to assess hypersomnolence).
Time frame: 14 days after baseline (Day 0)
Correlations will be explored between the severity score of the RLS and sleep parameters
assessed by actigraphy (specific measures including: Total Sleep Duration \[minutes\], Sleep Efficiency \[%\], Wake After Sleep Onset \[minutes\], and Sleep Onset Latency \[minutes\]) as well as scores from Ecological Momentary Assessment smartphone questionnaires.
Time frame: 14 days after baseline (Day 0)
Correlations will be explored between altered functional connectivity of the patients' insular cortex
(measured by statistical synchrony or temporal correlation of BOLD \[Blood Oxygen Level Dependent\] signals across different brain regions) and sleep parameters assessed by actigraphy (specific measures including Total Sleep Duration \[minutes\], Sleep Efficiency \[%\], Wake After Sleep Onset \[minutes\], and Sleep Onset Latency \[minutes\]) as well as scores from Ecological Momentary Assessment smartphone questionnaires. Comparisons will also be made with results obtained from the healthy volunteer group.
Time frame: 14 days after baseline (Day 0)
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.
Of 46 non-industry interventional studies with no phase under Restless Legs Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's planned 27 months is above that.
Counting every sponsor, half of 53 studies reached it within 12 months; a quarter within 5 and three quarters within 40.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Oct 2026 → Dec 2027 and completion Oct 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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