Therapy Light Rooms for Improved Sleep in Dementia Patients

NCT03357328 | Completed

• 2 other identifiers: UBergenDEM.LIGHT2016/2246
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Fragmentation; Behavioural and Psychiatric Symptoms of Dementia; Dementia

Keywords

Phototherapy; Nursing home; Light therapy

Outcome Measures

Primary Outcomes (3)

• Change in actigraphy recorded sleep and circadian rhythm

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

  Baseline and week 8, 16, and 24

• Change in proxy-rated sleep

  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

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

  Baseline and week 8, 16, and 24

Secondary Outcomes (17)

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

  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 Cornell Scale of Depression in Dementia (CSDD)

  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 Mobilization-Observation-Behaviour-Intensity-Dementia 2 (MOBID-2)

  Baseline and week 16 and 24

Study Arms (2)

Therapy light room

ACTIVE COMPARATOR

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

Standard light

PLACEBO COMPARATOR

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

Interventions

Therapy light room OTHER

See group description

Therapy light room

Standard light OTHER

See group description

Standard light

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5015, Norway

Location

Related Publications (3)

• 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.

  PMID: 34320937 DERIVED

• 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.

  PMID: 34001024 DERIVED

• 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.

  PMID: 32231600 DERIVED

MeSH Terms

Conditions

Sleep Deprivation; Dementia

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders

Study Officials

• Elisabeth Flo, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 29, 2017
• Study Start: September 25, 2017
• Primary Completion: April 21, 2018
• Study Completion: April 24, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

NO (1)