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Completed

NCT Number: NCT06595030

Investigating the Impact of Duration and Amount of Light on the Circadian System Response - Aim 3

Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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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 or related dementia with a Montreal Cognitive Assessment score <25
  • Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion criteria

  • Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
  • Obstructing cataracts
  • Severe macular degeneration
  • Use of sleep medication
  • Use of oral melatonin
  • untreated moderate to severe sleep apnea
  • Severe restless leg syndrome - Blindness

Treatment and study plan

Active lighting intervention

Device

The TLI will allow researchers to use a light source that will control how the circadian system is stimulated and provide the participants with options as to how the light treatment will be delivered.

Other names: TLI

Control lighting intervention

Device

The TLI will allow researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.

Other names: TLI

Primary outcomes

  1. Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Up to Week 36

    The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a full scale range of 0 to 21. A higher score indicates higher sleep disturbance.

Secondary outcomes

  1. Sleep efficiency using actigraphy

    Time frame: Up to Week 36

    Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping

  2. Depression using the Cornell Scale for Depression in Dementia (CSDD)

    Time frame: Up to Week 36

    The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. Full Scale ranges from 0 to 38 with a higher score indicating greater depression.

  3. Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: Up to Week 36

    The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior.

  4. Light measurements using the Daysimeter

    Time frame: Up to Week 36

    Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels.

  5. Cognitive status Using the Montreal Cognitive Assessment (MOCA)

    Time frame: Up to Week 36

    The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 17, 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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