Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients

NCT ID: NCT03483896

Last Updated: 2019-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2017-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. However, there are currently no minimum requirements for daylight access in care facilities. In urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight.

A 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. At 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 AM) each day. At the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. Outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia Depression Behavior Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Daylight Intervention

At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.

Group Type ACTIVE_COMPARATOR

Daylight Intervention

Intervention Type OTHER

Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Daylight Intervention

Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* physical co-morbidities that precluded participation in the daily group intervention
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyle Konis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kyle Konis, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alhambra Dementia Care

Alhambra, California, United States

Site Status

Sierra Vista Memory Care Community

Azusa, California, United States

Site Status

Calabasas Memory Care Community

Calabasas, California, United States

Site Status

Costa Mesa Dementia Care

Costa Mesa, California, United States

Site Status

Los Angeles Dementia Care (Beverly Place)

Los Angeles, California, United States

Site Status

Redondo Beach Dementia Care (Beach Cities)

Redondo Beach, California, United States

Site Status

San Juan Capistrano Memory Care Community

San Juan Capistrano, California, United States

Site Status

Tustin Hacienda Memory Care Community

Tustin, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UP-16-00487

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impact of Light on Mood
NCT06027944 UNKNOWN NA
Rhythm and Depression
NCT02857036 UNKNOWN NA
Light Therapy for Elderly Depression
NCT00332670 TERMINATED PHASE2/PHASE3