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Completed

NCT Number: NCT03357328

Therapy Light Rooms for Improved Sleep in Dementia Patients

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.

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Key information

Conditions

Sleep Fragmentation Behavioural and Psychiatric Symptoms of Dementia Brain Diseases Central Nervous System Diseases Dementia Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5015, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy light room

Other

See group description

Standard light

Other

See group description

Primary outcomes

  1. Change in actigraphy recorded sleep and circadian rhythm

    Time frame: Baseline and week 8, 16, and 24

    An actigraph (Actiwatch 2, Philips Respironics) is worn for 7 consecutive days

  2. Change in proxy-rated sleep

    Time frame: 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).

  3. Change in circadian rhythm of core body temperature

    Time frame: Baseline and week 8, 16, and 24

    A swallowed capsule (e-Celsius, BodyCap) records core body temperature for 24 hours.

Secondary outcomes

  1. Change in the Neuropsychiatric Inventory - Nursing Home version (NPI-NH)

    Time frame: Baseline and week 8, 16 and 24

    NPI-NH is a proxy-rated instrument to assess neuropsychiatric disturbances in people with dementia. A total score is calculated from the product of the frequency and severity of 12 items. The total score ranges from 0 (best) to 144 (worst).

  2. Change in the Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: Baseline and week 8, 16 and 24

    CMAI is a proxy-rated instrument measuring agitation symptoms. The instrument has 29 items, and the total score ranges from 29 (best) to 203 (worst).

  3. Change in the Cornell Scale of Depression in Dementia (CSDD)

    Time frame: Baseline and week 8, 16 and 24

    CSDD is a proxy-rated instrument addressing depression in people with dementia. The instrument has 19 items, and the total score ranges from 0 (best) to 38 (worst).

  4. Change in the Quality of Life in Late-Stage Dementia (QUALID)

    Time frame: Baseline and week 8, 16 and 24

    QUALID is a proxy-rated instrument validated for use in people with dementia. 11 behaviours are rated on a 5-point Likert scale, and the total score ranges from 11 (best) to 55 (worst).

  5. Change in the Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)

    Time frame: Baseline and week 16 and 24

    MOBID-2 is a proxy-rated instrument to assess pain in people with dementia. The instrument consists of two parts, each with five items. In part 1, pain intensity is inferred by the patient's pain behaviours during standardized, guided movements. In part 2, pain intensity is assessed by the patient's pain behaviours related to internal organs, head, and skin. A total score, ranging from 0-10, is set based on an overall assessment of the pain intensity scores in part 1 and 2.

  6. Change in the Mini Mental State Examination (MMSE)

    Time frame: Baseline and week 24

    MMSE is a cognitive function screening instrument, which discerns severity of cognitive impairment on a 30 point scale. Lower scores represent severe impairment.

  7. Change in the Functional Assessment Staging (FAST)

    Time frame: Baseline and week 8, 16 and 24.

    FAST is a proxy-rated instrument validated for use in people with dementia. It ascertains the severity of dementia in seven stages of functioning.

  8. Change in the Physical Self-Maintenance Scale

    Time frame: Baseline and week 8, 16 and 24

    Physical Self-Maintenance Scale assesses Activities of Daily living (ADL) pertaining to physical function. The scale consists of six items, and the total score ranges from 0 to 30. Lower values indicate better functioning.

  9. Clinical Global Impression of Change (CGIC)

    Time frame: Week 8, 16 and 24

    Rates globally perceived improvement ranging from very much worse (0) to very much improved (6). From baseline to week 8, 16 and 24.

  10. Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)

    Time frame: Baseline and week 8, 16 and 24

    RUD-FOCA is a cost-analysis of time invested in care during 24 hours

  11. Change in general health

    Time frame: Baseline and week 8, 16 and 24

    The medical journal will be used to register change in total use of medication, blood pressure, pulse, weight and diagnoses.

  12. Change in burden of care

    Time frame: Baseline and week 8, 16 and 24

    The NPI-NH total disruptiveness score is calculated by adding the occupational disruptiveness scores for the 12 items of the NPI-NH (each scored 0-5). The total disruptiveness score has a range of 0-60, with higher values representing more occupational disruptiveness.

  13. Change in staff alertness

    Time frame: Baseline and week 8, 16 and 24

    Karolinska Sleepiness Scale comprises a single item assessing state sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep).

  14. Change in staff sleep

    Time frame: Baseline and week 8, 16 and 24

    Bergen Insomnia Scale consists of six items. Each item is scored from 0 to 7, according to the number of days per week a specific insomnia symptom has occurred during the last month. The total score ranges from 0-42.

  15. Change in staff fatigue

    Time frame: Baseline and week 8, 16 and 24

    The Chalder Fatigue Questionnaire has 13 items. The first 11 items (scored 0-3) are used to calculate a total score with a range from 0-33. Higher values represent more fatigue.

  16. Change in staff mental health

    Time frame: Baseline and week 8, 16 and 24

    Measured by Hospital Anxiety and Depression Scale (HADS). HADS consists of two subscales, one for anxiety and one for depression, each with 7 items. The subscale scores range from 0 to 21. Higher values represent worse mental health (anxiety/depression).

  17. Change in staff health related quality of life

    Time frame: Baseline and week 8, 16 and 24

    The SF-12 health survey consists of 12 items. Two summary scores (the Mental Health Component Summary and the Physical Health Component Summary) are calculated based on an algorithm from the User's Manual for the SF-12 Health Survey.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)

Acronym: DEMLIGHT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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