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Trial record 1 of 1 for:    NCT 03357328
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Therapy Light Rooms for Improved Sleep in Dementia Patients (DEMLIGHT)

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ClinicalTrials.gov Identifier: NCT03357328
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bergen

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.

Condition or disease Intervention/treatment Phase
Sleep Fragmentation Behavioural and Psychiatric Symptoms of Dementia Dementia Other: Therapy light room Other: Standard light Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Therapy Light Rooms for Nursing Home Patients With Dementia - Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems (DEM.LIGHT)
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : April 21, 2018
Actual Study Completion Date : April 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: Therapy light room
See group description

Placebo Comparator: 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.
Other: Standard light
See group description




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357328


Locations
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Norway
University of Bergen
Bergen, Hordaland, Norway, 5015
Sponsors and Collaborators
University of Bergen
Investigators
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Principal Investigator: Elisabeth Flo, PhD University of Bergen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT03357328    
Other Study ID Numbers: UBergenDEM.LIGHT
2016/2246 ( Other Identifier: Regional committees for medical and health research ethics )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bergen:
Phototherapy
Nursing home
Light therapy
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Sleep Deprivation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyssomnias
Sleep Wake Disorders
Neurologic Manifestations