RLS Act-DM1 v1.4
Research type
Research Study
Full title
Prospective, single-arm, clinical-setting pilot study to assess the role of actigraphy in diagnosing Restless Legs Syndrome using the Actiwatch in patients with Myotonic Dystrophy type 1 (DM1).
IRAS ID
197451
Contact name
Kath Mares
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
Myotonic Dystrophy (DM) is the most common form of muscular dystrophy and is a progressive, genetic, neuromuscular disorder affecting around 1 in 8000 adults. DM is a multisystem disorder and patients can have a wide range of symptoms which can make diagnosis difficult. Diagnosis is currently made by neurological clinical examination and genetic testing, with counselling. A common co-morbidity (approx 80%) is Restless Legs Syndrome (RLS) which is a disorder that can create a feeling of discomfort and an irresistible urge to move the legs. This can be relieved by movement but the relief only lasts for the duration of the movement. RLS is most often experienced when relaxing before going to bed and in the transition into sleep. The sensations of RLS can cause involuntary movements typically in the legs, which is termed periodic limb movement (PLM). This movement is different to RLS as the movements are not voluntary. Both RLS and PLM have been reported in patients with DM1 and could contribute to impaired sleep, excessive daytime sleepiness and fatigue. The diagnosis of RLS forms part of the overall diagnosis of DM1. The current method for diagnosing RLS is by patients self-reporting the symptoms during consultation. There is no method of assessing RLS objectively. PLM can be objectively diagnosed with expensive overnight sleep studies in a specialised unit however the absence of PLM is not evidence that RLS is not present. This project aims to use an Actiwatch, an activity monitor made by Philips to record movements of the legs during sleep to identify if it can be used to help objectively diagnose RLS in DM1 patients. The Actiwatch can be used in the patient’s own home making the test more accessible to the patient and lower cost to the NHS.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0300
Date of REC Opinion
4 Aug 2016
REC opinion
Further Information Favourable Opinion