Methodology Issues in a Tailored Light Treatment for Persons With Dementia

NCT01816152 | Completed

• 2 other identifiers: GCO 20-40077R01AG034157-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sleep Disturbances; Depression

Keywords

light treatment; circadian rhythms; sleep; agitation; depression

Outcome Measures

Primary Outcomes (3)

• Sleep Disturbance

  Caregivers 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

  Change from Baseline (week 0) and intervention (week 4)

• Agitation

  Caregivers 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. All scores are summed for one total score - a higher score indicates more agitation

  Change from Baseline (week 0) and intervention (week 4)

• Depression

  Caregivers 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. A score greater than 12 indicates depression and a higher score indicates greater depression.

  Change from Baseline (week 0) and intervention (week 4)

Secondary Outcomes (3)

• Activity of Daily Living

  Change from Baseline (week 0) and intervention (week 4)

• Light/dark patterns

  Change from Baseline (week 0) and intervention (week 4)

• Actigraphy

  Change from Baseline (week 0) and intervention (week 4)

Study Arms (2)

Active Intervention

ACTIVE COMPARATOR

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

Other: Tailored Active intervention

Inactive intervention

PLACEBO COMPARATOR

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

Other: Inactive intervention

Interventions

Tailored Active intervention 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.

Active Intervention

Inactive intervention 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.

Inactive intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (4)

• Figueiro MG, Hamner R, Higgins P, Hornick T, Rea MS. Field measurements of light exposures and circadian disruption in two populations of older adults. J Alzheimers Dis. 2012;31(4):711-5. doi: 10.3233/JAD-2012-120484.

  PMID: 22699845 BACKGROUND

• Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645.

  PMID: 23099814 BACKGROUND

• Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.

  PMID: 25246779 RESULT

• Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.

  PMID: 31855161 DERIVED

MeSH Terms

Conditions

Parasomnias; Depression; Psychomotor Agitation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariana G Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Population Health Science and Policy

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 22, 2013
• Study Start: January 1, 2020
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (2)