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Bright Light Therapy in Older Adults With Moderate to Very Severe Dementia

NCT04949984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-07-08

No results posted yet for this study

Summary

INTRODUCTION: Bright light therapy (BLT) has demonstrated positive effects on sleep, mood, and behavioral problems in older adults with dementia. However, there is little research in people with advanced stages of dementia.

OBJECTIVES: Main objectives are to study the immediate effects, short and long-term effects of BLT in a sample of institutionalized older adults with moderate to very severe dementia. Later, to compare the potential effectiveness of bright light therapy sessions with other non-pharmacological interventions in people with dementia.

METHODS AND ANALYSIS: The study was a 2 x 2 randomized controlled trial using a two-group design (BLT vs. control) and two repeated measures (pre- vs. postintervention). In addition, the BLT group participants were assessed immediately before, after, and during each session. The BLT protocol consisted of 30-minute morning sessions of 10,000 lux, Monday through Friday, for 4 weeks.

For the statistical analysis, two-way analysis of variance (ANOVA) are used to determine the existence of differences at two points in time (pre- vs. post-). The Wilcoxon signed-rank test or the Paired t test are used to measure changes from before to after the intervention sessions.

Conditions

Interventions

DEVICE

Bright light therapy

BLT consisted of 30-minute morning sessions with an intensity of 10,000 lux, five days a week (Monday to Friday), for 4 weeks.

Sponsors & Collaborators

  • Universidade da Coruña

    lead OTHER

Principal Investigators

  • José C. Millán-Calenti · Universidade da Coruña

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949984 on ClinicalTrials.gov