Clinical trial NCT03357328: Therapy Light Rooms for Improved Sleep in Dementia Patients
Official title: Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Fragmentation
Behavioural and Psychiatric Symptoms of Dementia
Dementia
Keywords: Phototherapy
Nursing home
Light therapy
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 nursing home units will receive the intervention (ceiling mounted LED-light in the living room) and 4 will receive the control condition ("standard light"). The trial lasts for 24 weeks. Data will be collected at baseline and after 8, 16 and 24 weeks.
Primary purpose: TREATMENT

Brief 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.

Detailed description: People with dementia often have fragmented night-time sleep, prolonged night-time awakenings and increased daytime sleep. Behavioural and psychological symptoms of dementia (BPSD) (e.g. agitation, depression) are also common. Noticeably, both sleep problems and BPSD are related to a disturbed circadian rhythm. Light is the most important input to the circadian system, and exposure to sufficient daylight is important for entrainment of the circadian rhythm to the surroundings. Dementia patients living in nursing homes (NH) are less exposed to daylight than dementia patients living at home. Bright light therapy is a promising treatment in these patients as it may improve sleep, BPSD, and independent functioning. However, traditional bright light treatment has not been routinely employed in NH patients or patients with dementia. This may be related to difficulties in achieving adherence to the traditional treatment and thus the benefit of bright light therapy for people with dementia still remains unclear.

DEM.LIGHT uses modern LED (light-emitting diodes) technology that enables light therapy with the least possible interference of the day-to-day life in NHs, as the treatment is not confined to a light source presupposing behavioural compliance. Ceiling-mounted LED-sources can be programmed in terms of timing, light intensity and colour temperature. DEM.LIGHT uses this to provide therapy light rooms with a dynamic light condition that better emulates natural light throughout the day. The study is a cluster-randomized trial evaluating the effect of therapy light rooms on various measures of physical and mental health in NH patients with dementia. Data will be collected at baseline, after 8 and 16 weeks of treatment, and at the end of the intervention period (24 weeks).

Eligibility criteria: 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

Primary outcomes:
measure: Change in actigraphy recorded sleep and circadian rhythm
timeFrame: Baseline and week 8, 16, and 24
measure: Change in proxy-rated sleep
timeFrame: Baseline and week 8, 16, and 24
measure: Change in circadian rhythm of core body temperature
timeFrame: Baseline and week 8, 16, and 24
Secondary outcomes:
measure: Change in the Neuropsychiatric Inventory - Nursing Home version (NPI-NH)
timeFrame: Baseline and week 8, 16 and 24
measure: Change in the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Baseline and week 8, 16 and 24
measure: Change in the Cornell Scale of Depression in Dementia (CSDD)
timeFrame: Baseline and week 8, 16 and 24
measure: Change in the Quality of Life in Late-Stage Dementia (QUALID)
timeFrame: Baseline and week 8, 16 and 24
measure: Change in the Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)
timeFrame: Baseline and week 16 and 24
measure: Change in the Mini Mental State Examination (MMSE)
timeFrame: Baseline and week 24
measure: Change in the Functional Assessment Staging (FAST)
timeFrame: Baseline and week 8, 16 and 24.
measure: Change in the Physical Self-Maintenance Scale
timeFrame: Baseline and week 8, 16 and 24
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Week 8, 16 and 24
measure: Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
timeFrame: Baseline and week 8, 16 and 24
measure: Change in general health
timeFrame: Baseline and week 8, 16 and 24
measure: Change in burden of care
timeFrame: Baseline and week 8, 16 and 24
measure: Change in staff alertness
timeFrame: Baseline and week 8, 16 and 24
measure: Change in staff sleep
timeFrame: Baseline and week 8, 16 and 24
measure: Change in staff fatigue
timeFrame: Baseline and week 8, 16 and 24
measure: Change in staff mental health
timeFrame: Baseline and week 8, 16 and 24
measure: Change in staff health related quality of life
timeFrame: Baseline and week 8, 16 and 24
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Elisabeth Flo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolberg E, Hjetland GJ, Thun E, Pallesen S, Nordhus IH, Husebo BS, Flo-Groeneboom E. The effects of bright light treatment on affective symptoms in people with dementia: a 24-week cluster randomized controlled trial. BMC Psychiatry. 2021 Jul 28;21(1):377. doi: 10.1186/s12888-021-03376-y.
citation: Hjetland GJ, Kolberg E, Pallesen S, Thun E, Nordhus IH, Bjorvatn B, Flo-Groeneboom E. Ambient bright light treatment improved proxy-rated sleep but not sleep measured by actigraphy in nursing home patients with dementia: a placebo-controlled randomised trial. BMC Geriatr. 2021 May 17;21(1):312. doi: 10.1186/s12877-021-02236-4.
citation: Hjetland GJ, Nordhus IH, Pallesen S, Cummings J, Tractenberg RE, Thun E, Kolberg E, Flo E. An Actigraphy-Based Validation Study of the Sleep Disorder Inventory in the Nursing Home. Front Psychiatry. 2020 Mar 13;11:173. doi: 10.3389/fpsyt.2020.00173. eCollection 2020.