The difference between Bright Light Therapy and Biodynamic Lighting for patiënts with moderate-to-severe dementia: a double-blind, randomized, placebo-controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29349

Enrollment

Registered

2018-08-13

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Alzheimer's disease, Frontotemporal dementia, Vascular dementia, Lewy-body dementia, bright light, biodynamic light, circadian rhytm, cognition, mood, quality of life

Interventions

The group patiënts (N = 60) are divided over 6 living rooms of a nursing home 'Atlant' in Apeldoorn, The Netherlands. All patiënts are exposed to bright light therapy (lux 1000-2500, 10 AM- 6 PM), C

Eligibility

Inclusion criteria

Inclusion criteria: - Patiënts with a clear diagnosis of dementia according to the ICD-10 and/or DSM criteria - Patiënts with dementia staying in a long-term care nursing home 'Atlant Zorggroep' in Apeldoorn - The Netherlands

Exclusion criteria

Exclusion criteria: - Patiënts without a clear diagnosis of dementia according to the ICD-10 and/or DSM criteria - Patiënts who are terminally ill (life expectation < 4 weeks according to physican) - Patiënts and legal representatives who refused to complete the informed consent form. - Patiënts with a serious eye disease incompatible with light therapy, such as aphakia or retinitis pigmentosa.

Design outcomes

Primary

Measure	Time frame
- Cognition (SIB-II, MMSE) - Quality of life (QUALIDEM) - Depression (MADRS) - Apathy (NPI-NH Apathy scale) - Agitation (CMAI) - Rest-activity Rythm (actigraphy) - Activities of Daily Life (Katz-ADL)	—

Secondary

Measure	Time frame
- Dementia Severity (GDS) - Year diagnosis dementia - Dementia Types - Age - Gender - Education Level (according to verhage criteria) - Medical comorbidities in the last 6 months - Medication use in the last 6 months - Presence/absence of walking function - falls incidence (number of falls a month before and during the study). - Lux measurement: Before, after and during the intervention the light intensity will be measured by the supplier. During the intervention the light intensity will be independently measured by a luxmeter at the eye level in the gaze direction. The measurements take place two times in the week at the same time (12 o'clock PM) - Light colour: Before, after and during the intervention the light colour (kelvin) will be measured by the supplier.	—

Measure

Time frame

- Dementia Severity (GDS) - Year diagnosis dementia - Dementia Types - Age - Gender - Education Level (according to verhage criteria) - Medical comorbidities in the last 6 months - Medication use in the last 6 months - Presence/absence of walking function - falls incidence (number of falls a month before and during the study). - Lux measurement: Before, after and during the intervention the light intensity will be measured by the supplier. During the intervention the light intensity will be independently measured by a luxmeter at the eye level in the gaze direction. The measurements take place two times in the week at the same time (12 o'clock PM) - Light colour: Before, after and during the intervention the light colour (kelvin) will be measured by the supplier.

—

Contacts

Public ContactAngela Joanna Prins

Angela.Prins@atlant.nl055 506 72 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)