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Methodology Issues in a Tailored Light Treatment for Persons With Dementia

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ClinicalTrials.gov Identifier: NCT01816152
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mariana G Figueiro, Rensselaer Polytechnic Institute

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

Condition or disease Intervention/treatment Phase
Sleep Disturbances Depression Other: Tailored Active intervention Other: Inactive intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Study Start Date : December 2010
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Active Comparator: Active Intervention
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
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.

Placebo Comparator: Inactive intervention
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
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.




Primary Outcome Measures :
  1. Sleep Disturbance [ Time Frame: Change from Baseline (week 0) and intervention (week 4) ]
    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

  2. Agitation [ Time Frame: Change from Baseline (week 0) and intervention (week 4) ]
    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

  3. Depression [ Time Frame: Change from Baseline (week 0) and intervention (week 4) ]
    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.


Secondary Outcome Measures :
  1. Activity of Daily Living [ Time Frame: Change from Baseline (week 0) and intervention (week 4) ]
    Caregivers 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. Light/dark patterns [ 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.

  3. Actigraphy [ 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mild to moderate Alzheimer's disease and related dementia (ADRD) based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria,
  • Clinical Dementia Rating (CDR) of 1 to 2,
  • Mini-Mental State Examination (MMSE) between 8 and 24

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816152


Locations
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United States, New York
ALbany County Nursing Home
Albany, New York, United States, 12180
Teresian House
Albany, New York, United States, 12180
Hawthorne Ridge
East Greenbush, New York, United States, 12180
Sponsors and Collaborators
Rensselaer Polytechnic Institute
Investigators
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Principal Investigator: Mariana G Figueiro, PhD Rensselaer Polytechnic Institute

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariana G Figueiro, Professor, Rensselaer Polytechnic Institute
ClinicalTrials.gov Identifier: NCT01816152    
Other Study ID Numbers: R01AG034157 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Mariana G Figueiro, Rensselaer Polytechnic Institute:
light treatment
circadian rhythms
sleep
agitation
depression
Additional relevant MeSH terms:
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Dementia
Dyssomnias
Sleep Wake Disorders
Parasomnias
Depression
Behavioral Symptoms
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Neurologic Manifestations
Signs and Symptoms