A Pilot Randomised Trial of Light Therapy in People with Dementia
Research type
Research Study
Full title
Disturbances of Sleep in Dementia (DOSID): A Study to Evaluate the Feasibility of Conducting a Phase II- Randomized Controlled Cross-Over Trial Evaluating the Efficacy and Exploring the Mechanisms of Bright Full Spectrum Light as a Therapy for Sleep Disturbances in People with Dementia
IRAS ID
174000
Contact name
David P Lowery
Contact email
Sponsor organisation
SABP NHS Trust
Duration of Study in the UK
0 years, 6 months, 5 days
Research summary
Two thirds of people with dementia have problems with sleep. This can cause stress and influence decisions to move the person into a care home. Medications prescribed for sleep disturbances may have negative side effects and we cannot be sure they work. Non-drug methods are recommended, but need to be evaluated.
A hormone released from the brain determines when people fall asleep. If someone is exposed to bright light, the brain stops the release of this hormone and this can disrupt sleep. Without this regular cue to stay awake, a person may naturally sleep at different times of the day.
Exposure to enough light may become difficult with age and worsening dementia. Giving bright blue/white light to help people stay awake during the day may help reduce problems with sleep at night. There have been some studies, but because of weaknesses in the way the research has been carried out, they have not led to a conclusion on treatment.
We will test if a light box used during the day helps people with dementia sleep better at night. To do this we plan to invite people with dementia to take part. We will give each person a light box to use each day in their own home. Over 9 weeks they will receive two different boxes. One will deliver active bright blue/white light and the other inactive dim red light. The order in which the person receives the different light treatments will be determined by chance. We will ask people to wear a device that looks like a watch to record their movement in bed. This is a good way of recording people’s sleep behaviour. If the treatment works, we would expect people to sleep for longer at night during the bright blue/white light treatment period, than during the dim red light treatment period.
This is difficult research to carry out, but we think it can be done. Our group includes experts in this type of research. We have previously carried out similar studies looking at non-drug treatments for symptoms of dementia. However, we want to make absolutely sure that we can do the study in the way that we plan before we start. Therefore, we will start with a small pilot study and ask only 6 people to take part. This will tell us whether we can recruit enough people; whether they use the light box in the way we prescribe; and whether we can carry out all our planned assessments.
After we have tried our plans in the pilot study we will not be able to comment on whether light therapy works, but we will be able to say whether it would be worthwhile to ask more people to take part. We will then refine our plans and apply for funding to carry out a full trial. We will then make a separate application for ethical approval to carry out that study.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1350
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion