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Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Primary Purpose

Sleep Disturbances, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Active intervention
Inactive intervention
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbances focused on measuring light treatment, circadian rhythms, sleep, agitation, depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Intervention

Inactive intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

Activity of Daily Living
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.
Light/dark patterns
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.
Actigraphy
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 Information

First Posted
March 15, 2013
Last Updated
July 7, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01816152
Brief Title
Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Official Title
Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbances, Depression
Keywords
light treatment, circadian rhythms, sleep, agitation, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Intervention
Arm Type
Active Comparator
Arm Description
Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients.
Arm Title
Inactive intervention
Arm Type
Placebo Comparator
Arm Description
Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients
Intervention Type
Other
Intervention Name(s)
Tailored Active intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inactive intervention
Intervention Description
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 Measure Information:
Title
Sleep Disturbance
Description
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
Time Frame
Change from Baseline (week 0) and intervention (week 4)
Title
Agitation
Description
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
Time Frame
Change from Baseline (week 0) and intervention (week 4)
Title
Depression
Description
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.
Time Frame
Change from Baseline (week 0) and intervention (week 4)
Secondary Outcome Measure Information:
Title
Activity of Daily Living
Description
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.
Time Frame
Change from Baseline (week 0) and intervention (week 4)
Title
Light/dark patterns
Description
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.
Time Frame
Change from Baseline (week 0) and intervention (week 4)
Title
Actigraphy
Description
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.
Time Frame
Change from Baseline (week 0) and intervention (week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana G Figueiro, PhD
Phone
518 3669306
Email
mariana.figueiro@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana G Figueiro, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
Albany
State/Province
New York
ZIP/Postal Code
12204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Plitnick, BSN
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mariana G Figueiro, PhD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Plitnick, BSN
Phone
212-659-9693
Email
barbara.plitnick@mountsinai.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
22699845
Citation
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.
Results Reference
background
PubMed Identifier
23099814
Citation
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.
Results Reference
background
PubMed Identifier
25246779
Citation
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.
Results Reference
result
PubMed Identifier
31855161
Citation
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.
Results Reference
derived

Learn more about this trial

Methodology Issues in a Tailored Light Treatment for Persons With Dementia

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