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OpenTrials
Completed

NCT Number: NCT05519137

Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Light and Health Research Center

Menands, New York, 12204, United States

About this study

Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
  • a score >5 on the PSQI.

Exclusion criteria

  • use of sleep medication

Treatment and study plan

Active lighting intervention

Device

Lighting intervention designed to impact the circadian system

Control lighting intervention

Device

Lighting intervention designed to have no impact on the circadian system

Primary outcomes

  1. Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and post intervention (8 weeks)

    The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score >5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance.

Secondary outcomes

  1. Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD)

    Time frame: Baseline and post intervention (8 weeks)

    The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms.

  2. Sleep Efficiency Measured by Actigraphy

    Time frame: Baseline and post intervention (8 weeks)

    Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage.

  3. Sleep Burden Using The Sleep Disorders Inventory (SDI)

    Time frame: Baseline and post intervention (8 weeks)

    Full scale from 0 to 56, with higher score indicating greater sleep disturbance

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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