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Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Primary Purpose

Alzheimer's Disease, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Lighting Intervention
Control Lighting 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 Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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 Lighting Intervention

Control Lighting Intervention

Arm Description

Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.

Lighting intervention using low light levels designed to not effect the circadian system

Outcomes

Primary Outcome Measures

Sleep Disturbance using the Pittsburgh Sleep Quality Index
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 range of 0 to 21. A higher score indicates higher sleep disturbance

Secondary Outcome Measures

Sleep efficiency using actigraphy
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.
Depression using the Cornell Scale for Depression in Dementia (CSDD)
The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression.
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
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.
Light measurements using the Daysimeter
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.
Cognitive status Using the Montreal Cognitive Assessment (MOCA)
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.

Full Information

First Posted
April 20, 2023
Last Updated
April 20, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05837819
Brief Title
Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Official Title
Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Lighting Intervention
Arm Type
Active Comparator
Arm Description
Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.
Arm Title
Control Lighting Intervention
Arm Type
Placebo Comparator
Arm Description
Lighting intervention using low light levels designed to not effect the circadian system
Intervention Type
Device
Intervention Name(s)
Active Lighting Intervention
Intervention Description
Lighting intervention using high light levels designed to effect the circadian system
Intervention Type
Device
Intervention Name(s)
Control Lighting Intervention
Intervention Description
Lighting intervention using low light levels designed to not effect the circadian system
Primary Outcome Measure Information:
Title
Sleep Disturbance using the Pittsburgh Sleep Quality Index
Description
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 range of 0 to 21. A higher score indicates higher sleep disturbance
Time Frame
up to week 14
Secondary Outcome Measure Information:
Title
Sleep efficiency using actigraphy
Description
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.
Time Frame
up to week 14
Title
Depression using the Cornell Scale for Depression in Dementia (CSDD)
Description
The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression.
Time Frame
up to week 14
Title
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
Description
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.
Time Frame
up to week 14
Title
Light measurements using the Daysimeter
Description
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.
Time Frame
up to week 14
Title
Cognitive status Using the Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
up to week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Plitnick
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana 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
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mariana 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
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mariana Figueiro, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Overall results will be shared, not individual data

Learn more about this trial

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

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