Melatonin treatment for sleep disturbance in ocular disorders:Sandman
Research type
Research Study
Full title
A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease.
IRAS ID
161802
Contact name
Susan Downes
Contact email
Sponsor organisation
Univeristy of Oxford
Eudract number
2017-002189-39
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
Sleep/wake disruption is often reported as a significant problem by visually impaired patients. However, to date there have been few studies relating to sleep disturbance in humans with ocular disease.
Melatonin is a natural hormone produced in healthy individuals by the pineal gland. It is considered to be one of the most reliable markers of the periodicity of the body clock. Its production is highly rhythmic and high levels are found at night-and low levels in the day time in normally entrained-sighted individuals.
The hypothesis is that melatonin could regulate the sleep/wake cycle and sleep disturbance, in people with eye disorders.
Participants with sleep wake disturbance as evidenced by an abnormally elevated PSQI score will be identified from the current Sleep study, “Effect of Ocular Diseases on Sleep and ‘Body-Clocks’ (Circadian Rhythms)” (REC Reference: 11/SC/0093).
Participants will be asked to complete 7 questionnaires (Pittsburgh Sleep Quality Index (PSQI), Jupiter Sleep Questionnaire, General Health Questionnaire, SF-36 Questionnaire, Morningness-Eveningness (LARK/OWL) Questionnaire, Pictorial Epworth Sleepiness Scale, and the Hospital Anxiety and Depression Scale), undergo urinalysis, actigraphy and complete sleep diaries they will then be randomised to receive either nightly melatonin or nightly placebo.
The study is being funded by grants from the Wellcome Trust and from Fight for Sight.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1226
Date of REC Opinion
1 Aug 2017
REC opinion
Favourable Opinion