Plain English Summary
Background and study aims
Two out of three 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 we are not sure they work either. 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. This is difficult research to carry out, but we think it can be done. Our group includes experts with experience in this type of research. 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 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 small study we will not be able to comment on whether light treatment works, but we will be able to say whether it would be worthwhile to ask more people to take part. We will then finalise our plans for a larger study.
Who can participate?
People with Alzheimer's type dementia and an irregular sleep wake pattern.
What does the study involve?
Each participant is given a light box to use each day in their own home. Over the 9 weeks, the participants are given two different light boxes at two different times. One is an active bright blue/white light box and the other is an inactive dim red light box. The order in which the person receives the different light treatments is determined by chance. We compare how people sleep during the two periods to see if either of the light boxes is better. To measure sleep, participants 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 period they are regularly using the bright blue/white light box, in comparison to the period they are using the dim red light box.
What are the possible benefits and risks of participating?
Participants may benefit from improvements of their sleep, mood, ability to think and remember clearly, quality of life, and feelings of self-determination. Participants may also experience improvement in their ability to go about their everyday activities, including social activities. Further benefits could include a reduced need for medication and less stress and distress. Aside from the time commitment of participating, potential side effects include headaches, dry mouth, mild agitation or irritability.
Where is the study run from?
Surrey & Borders Partnership NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
December 2015 to June 2016.
Who is funding the study?
University of Kent (UK).
Who is the main contact?
Dr David Lowery
Trial website
Contact information
Type
Public
Primary contact
Dr David Lowery
ORCID ID
http://orcid.org/0000-0002-0730-3130
Contact details
Centre for Health Services Studies
2nd Floor George Allen Wing
Cornwallis Building
University of Kent
Canterbury
CT2 7NF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2.6.2
Study information
Scientific title
Disturbances of Sleep in Dementia (DOSID): a pilot randomized controlled cross-over trial to evaluate the efficacy and explore the mechanisms of bright full spectrum light as a therapy for sleep disturbances in people with dementia
Acronym
DOSID
Study hypothesis
Bright full spectrum light therapy will effectively improve objectively measured sleep behaviour (actigraphy). This hypothesis predicts light therapy will: increase total night time sleep (sleep duration); reduce the duration of time spent awake in bed after the initial onset of sleep (sleep efficiency) and reduce daytime napping.
Bright full spectrum light therapy will effectively improve subjective reported sleep quality (Leeds Sleep Evaluation Questionnaire [LSEQ]). This hypothesis predicts that participant’s scores on the LSEQ will decrease with the use of light therapy.
Ethics approval
London - Bromley Research Ethics Committee under the auspices of the NHS Health Research Authority, 1. 20/11/2015, ref: 15/LO/1350
Study design
Randomised controlled double-blind cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Irregular sleep wake disturbance in people with dementia
Intervention
We will evaluate the efficacy of a full spectrum bright light box (~10,000 Lux; ~460nm) as a therapy for sleep disturbances within a cohort of community dwelling people with dementia by means of a randomised, controlled, double-blind, cross-over trial with two treatments: active bright light box (A), or a control dim red light box (B). In addition to treatment as usual, participants will be randomly allocated to one of two treatment sequences (AB or BA).
Intervention type
Device
Phase
Drug names
Primary outcome measure
Sleep behaviour (actigraphy), measured at Baseline, Week 3, Week 6 (Baseline 2), Week 9
*This study is a cross-over trial, so has two baseline assessments.
Secondary outcome measures
1. Dim Light Melatonin Onset (saliva)
2. Neuropsychiatric Inventory (NPI)
3. Mini-Mental State Evaluation (MMSE)
4. Leeds Sleep Evaluation Questionnaire (LSEQ)
5. Zarit Caregiver Burden Interview (ZBI)
Measured at Baseline, Week 3, Week 6 (Baseline 2), Week 9
*This study is a cross-over trial, so has two baseline assessments.
Overall trial start date
01/12/2015
Overall trial end date
01/06/2016
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Alzheimer's type dementia
2. Irregular sleep wake pattern
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6 (pilot only)
Participant exclusion criteria
1. 'Severe' dementia
2. Sleep apnoea
3. Eye disease
4. Abnormal visual acuity
5. Parkinson's disease
6. Restless leg syndrome
7. Periodic limb movement
8. History of light-induced migraine or epilepsy
9. Using photosensitising medication
10. Trans-meridian travel or shift work
11. Bipolar affective disorder
Recruitment start date
07/12/2015
Recruitment end date
07/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surrey & Borders Partnership NHS Foundation Trust
KT16 0 AE
United Kingdom
Sponsor information
Organisation
University of Kent (UK)
Sponsor details
Registry
University of Kent
Canterbury
CT2 7NZ
United Kingdom
Sponsor type
University/education
Website
Organisation
Surrey & Borders Partnership NHS Foundation Trust
Sponsor details
18 Mole Business Park
Randalls Road
Leatherhead
KT22 7AD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Organisation
University of Kent
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
University/education
Funder name
University of Kent
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
In 2016 we plan to publish the protocol in a peer-reviewed journal.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list