Using mobile technology to assess symptoms 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
This study is testing if using a mobile app can help people with Restless Legs Syndrome track their symptoms and see how daily habits like exercise and sleep affect their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05695963 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the feasibility of using mobile technology to collect real-time data on symptom severity fluctuations in patients with Restless Legs Syndrome (RLS). By employing Ecological Momentary Assessment (EMA), the study will gather information on daily life risk factors that may influence the onset or worsening of RLS symptoms. The research will focus on understanding how health-related behaviors, such as physical activity and sleep quality, impact the condition. The ultimate goal is to provide insights that could lead to improved management strategies for RLS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 diagnosed with idiopathic Restless Legs Syndrome.
Not a fit: Patients with significant psychiatric illnesses or other chronic conditions that could confound the results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of Restless Legs Syndrome, potentially improving patients' quality of life.
How similar studies have performed: While the use of mobile technology for symptom tracking is gaining traction, this specific approach in RLS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
Where this trial is running
Bordeaux
- CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Imad Marc Antoine GHORAYEB, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Imad Marc Antoine GHORAYEB, MD, PhD
- Email: marc-antoine.ghorayeb@chu-bordeaux.fr
- Phone: (0)5.56.79.55.13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.