Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in actigraphy recorded sleep and circadian rhythm
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Although the placebo effect might not be an issue in those with severe dementia, the treatment may affect staff, creating bias such as the Hawthorne effect. Potential changes in staff routines and behaviours in response to the treatment may affect outcome, making a control condition necessary. In this controlled trial, we will compare patients receiving the intervention (therapy light rooms) with control units receiving placebo light ("standard light"). The researchers will install the same standard light solution (100 lux at eye level, 3000K) in all control units. This represents the placebo light intervention, which at the same time ensures a constant standard light condition in all control units.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Therapy light room
This group (4 NH units, about 35 patients) will receive light therapy administered via LED technology. The light will vary in intensity and colour temperature throughout the day. Ceiling-mounted LED-lights are installed in the living rooms of participating nursing home units. Between 07:00 and 10:00 light of 400 lux at eye level, with 4000 K, will be provided. Between 10:00 and 15:00 the light will comprise 1000 lux at eye level, with 6000 K. From 15:00 to 18:00 the light will comprise 400 lux at eye level and 4000 K. When light is on from 18:00 to 07:00, standard light (about 100 lux at eye level, 3000K) will be administered.
干预措施: Therapy light room (Other)
Standard light
This group (4 NH units, about 35 patients) will receive "standard light" (100 lux at eye level, 3000K). The light will be administered between 07:00 and 18:00; and the same when light is on between 18:00 to 07:00. This represents the placebo light intervention, which at the same time ensures a constant standard light condition in all control units.
干预措施: Standard light (Other)
结局指标
主要结局
Change in actigraphy recorded sleep and circadian rhythm
时间窗: Baseline and week 8, 16, and 24
An actigraph (Actiwatch 2, Philips Respironics) is worn for 7 consecutive days
Change in proxy-rated sleep
时间窗: Baseline and week 8, 16, and 24
Sleep Disorders Inventory (a proxy-rated instrument) is completed. A total score is calculated from the product of the average frequency and average severity of seven symptoms. The total score ranges from 0 (best) to 12 (worst).
Change in circadian rhythm of core body temperature
时间窗: Baseline and week 8, 16, and 24
A swallowed capsule (e-Celsius, BodyCap) records core body temperature for 24 hours.
次要结局
- Change in the Cornell Scale of Depression in Dementia (CSDD)(Baseline and week 8, 16 and 24)
- Change in the Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)(Baseline and week 16 and 24)
- Change in general health(Baseline and week 8, 16 and 24)
- Change in staff alertness(Baseline and week 8, 16 and 24)
- Change in the Mini Mental State Examination (MMSE)(Baseline and week 24)
- Clinical Global Impression of Change (CGIC)(Week 8, 16 and 24)
- Change in staff mental health(Baseline and week 8, 16 and 24)
- Change in the Cohen-Mansfield Agitation Inventory (CMAI)(Baseline and week 8, 16 and 24)
- Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)(Baseline and week 8, 16 and 24)
- Change in staff health related quality of life(Baseline and week 8, 16 and 24)
- Change in the Neuropsychiatric Inventory - Nursing Home version (NPI-NH)(Baseline and week 8, 16 and 24)
- Change in the Quality of Life in Late-Stage Dementia (QUALID)(Baseline and week 8, 16 and 24)
- Change in the Functional Assessment Staging (FAST)(Baseline and week 8, 16 and 24.)
- Change in the Physical Self-Maintenance Scale(Baseline and week 8, 16 and 24)
- Change in burden of care(Baseline and week 8, 16 and 24)
- Change in staff sleep(Baseline and week 8, 16 and 24)
- Change in staff fatigue(Baseline and week 8, 16 and 24)