Back to resultsUsing a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active lighting intervention
Control lighting intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion criteria:
- Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
- a score >5 on the PSQI.
Exclusion criteria:
- use of sleep medication
Sites / Locations
- Light and Health Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Active lighting intervention then Control lighting condition
Control lighting condition then Active light intervention
Arm Description
Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Outcomes
Primary Outcome Measures
Sleep disturbance using the Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score >5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance.
Secondary Outcome Measures
Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)
The CSDD is a 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. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms.
Sleep efficiency measured by actigraphy
Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage.
Full Information
NCT ID
NCT05519137
First Posted
August 25, 2022
Last Updated
June 6, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05519137
Brief Title
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Official Title
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)
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
To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.
Detailed Description
Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will randomly be assigned to initially receive the active or control lighting intervention
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active lighting intervention then Control lighting condition
Arm Type
Active Comparator
Arm Description
Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Arm Title
Control lighting condition then Active light intervention
Arm Type
Active Comparator
Arm Description
Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.
Intervention Type
Device
Intervention Name(s)
Active lighting intervention
Intervention Description
Lighting intervention designed to impact the circadian system
Intervention Type
Device
Intervention Name(s)
Control lighting intervention
Intervention Description
Lighting intervention designed to have no impact on the circadian system
Primary Outcome Measure Information:
Title
Sleep disturbance using the Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score >5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance.
Time Frame
up to 22 weeks
Secondary Outcome Measure Information:
Title
Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)
Description
The CSDD is a 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. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms.
Time Frame
up to 22 weeks
Title
Sleep efficiency measured by actigraphy
Description
Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage.
Time Frame
up to 22 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
a score >5 on the PSQI.
Exclusion criteria:
- use of sleep medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Figueiro, PhD
Organizational Affiliation
Mount Sinai Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Light and Health Research Center
City
Menands
State/Province
New York
ZIP/Postal Code
12204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Since this data collection occurs in a population with Alzheimer's disease, participants are generally not interested in individual results.
Learn more about this trial
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
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