Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-05-10

Brief Summary

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Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia

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Detailed Description

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In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.

Conditions

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Sleep Disturbances Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active Intervention

Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients.

Group Type ACTIVE_COMPARATOR

Tailored Active intervention

Intervention Type OTHER

Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.

Inactive intervention

Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients

Group Type PLACEBO_COMPARATOR

Inactive intervention

Intervention Type OTHER

Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.

Interventions

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Tailored Active intervention

Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.

Intervention Type OTHER

Inactive intervention

Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* mild to moderate Alzheimer's disease and related dementia (ADRD)

Exclusion Criteria

* major organ failure,
* major illness,
* history of head injury,
* hypertension or diabetes,
* use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes