Therapy Light Rooms for Improved Sleep in Dementia Patients (NCT03357328) | Clinical Trial Compass
CompletedNot Applicable
Therapy Light Rooms for Improved Sleep in Dementia Patients
Norway70 participantsStarted 2017-09-25
Plain-language summary
This intervention study will investigate the effect of therapy light rooms on sleep, circadian rhythms, mood, behavioural problems and function in nursing home (NH) patients with dementia.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 60 years or more of age and in long term care (longer than 4 weeks)
* have dementia in accordance with DSM-V
* have either sleep/circadian rhythm disturbances, BPSD as identified by NPI-NH, or severely reduced ADL function
* provide written informed consent if the participant has capacity, if not, a written proxy informed consent from a legally authorized representative
Exclusion Criteria:
* are blind or may otherwise not benefit from light
* partake in another trial
* have a condition contra-indicated to the intervention
* have an advanced, severe medical disease/disorder and/or expected survival of less than 6 months or other aspects that could interfere with participation
* are psychotic or have a severe mental disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in actigraphy recorded sleep and circadian rhythm
Timeframe: Baseline and week 8, 16, and 24
2
Change in proxy-rated sleep
Timeframe: Baseline and week 8, 16, and 24
3
Change in circadian rhythm of core body temperature