Sleep in HD - Version 1.0
Research type
Research Study
Full title
Sleep and circadian disturbances and their treatment in Huntington's disease
IRAS ID
167695
Contact name
Roger A Barker
Contact email
Sponsor organisation
Cambridge University Hospital NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Huntington's disease (HD) is a fatal autosomal dominant neurodegenerative condition that affects approximately 14 to 16 individuals per 100,000 and typically presents in midlife. HD is characterized by progressively worsening motor and non-motor deficits including cognitive, neuropsychiatric disorders, weight loss, and severe sleep disturbances. There is no curative treatment for this disease. There are multiple studies showing that sleep problems are present early on during the disease process or even before disease onset. Sleep and circadian rhythm disruption are increasingly recognized as contributing to a wide range of health problems as well as cognitive deficits and even mortality. A bidirectional relationship may exist between neurodegeneration and sleep/circadian disorders. Therefore we think that one of possible therapeutic approach for this incurable disease can be to improve circadian entrainment and sleep quality. This assumption is based on research data showing that pharmaceutical or behavioural interventions aiming at improving sleep-wake rhythmicity can slow down the disease process in transgenic animal models of HD. Bright light therapy (daily exposure to bright light) and sleep restriction therapy (the minimization time spent in bed without sleep) has been shown to improve circadian entrainment and sleep quality in various patients group. However, no studies have been performed in HD.
We plan to perform a non-pharmaceutical intervention using bright light therapy versus sleep restriction therapy in 50 patients with HD, plus 30 controls. The study will follow a randomized open label parallel design involving a home based (activity-rest monitoring using actigraphy) and laboratory based (polysomnography) sleep study twice, a baseline and a follow-up session separated by a six week-long treatment period involving bright light versus sleep restriction therapy. Plus 20 month follow up. For those participants not interested in the sleep intervention, we would invite them to take part in one night sleep follow up every 20 months.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0445
Date of REC Opinion
22 Dec 2015
REC opinion
Favourable Opinion