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Completed

NCT Number: NCT01816152

Methodology Issues in a Tailored Light Treatment for Persons With Dementia

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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Key information

Conditions

Sleep Disturbances Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Depression Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, Albany, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

High Active intervention

Other

The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.

Inactive intervention

Other

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.

Mid Level Active Intervention

Other

The Mid level 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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance

  2. Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. 29 item instrument, each item scored 1-7. Total range score from 29-203 - a higher score indicates more agitation

  3. Cornell Scale for Depression in Dementia (CSDD) Questionnaire

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score range 0-38. A score greater than 12 indicates depression and a higher score indicates greater depression.

Secondary outcomes

  1. Activity of Daily Living Questionnaire (MDS-ADL)

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence.

  2. Circadian Stimulus Dose

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. Circadian stimulus (CS) is the amount of light needed to activate the circadian system. The range is 0 to 0.6 the higher the number the greater the CS dose

  3. Sleep Efficiency Score

    Time frame: Change from Baseline (week 0) and intervention (week 4)

    Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. Full scale score from 0-100, higher score indicates better efficiency.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2013
Registry last updated
Jul 27, 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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