Therapy Light Rooms for Improved Sleep in Dementia Patients (DEMLIGHT)

May 4, 2018 updated by: University of Bergen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5015
        • University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and week 8, 16, and 24
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).
Baseline and week 8, 16, and 24
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.
Baseline and week 8, 16, and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and week 8, 16 and 24
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).
Baseline and week 8, 16 and 24
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).
Baseline and week 8, 16 and 24
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).
Baseline and week 8, 16 and 24
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.
Baseline and week 16 and 24
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.
Baseline and week 24
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.
Baseline and week 8, 16 and 24.
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.
Baseline and week 8, 16 and 24
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.
Week 8, 16 and 24
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
Baseline and week 8, 16 and 24
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.
Baseline and week 8, 16 and 24
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.
Baseline and week 8, 16 and 24
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).
Baseline and week 8, 16 and 24
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.
Baseline and week 8, 16 and 24
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.
Baseline and week 8, 16 and 24
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).
Baseline and week 8, 16 and 24
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.
Baseline and week 8, 16 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Investigators

  • Principal Investigator: Elisabeth Flo, PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

April 21, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBergenDEM.LIGHT
  • 2016/2246 (Other Identifier: Regional committees for medical and health research ethics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Therapy light room

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe