CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Bright light therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04949984
NCT04949984N/ACompleted

Bright Light Therapy in Older Adults With Moderate to Very Severe Dementia: Effects on Cognition, Mood, Behavior, and Physiological Parameters

Universidade da Coruña·interventional·Posted Jul 2, 2021·Updated Jul 8, 2021

In Brief

A clinical study evaluating Bright light therapy for Dementia and 2 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Mood, Behavior
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2021
Enrollment StartJan 8, 2018
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5 years ago

Interventions

Bright light therapydevice

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