Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

Alzheimer's Disease Clinical Trial

Official title:

Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519137
• Other study ID #: STUDY-20-01772
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Device:
• Active lighting intervention
Lighting intervention designed to impact the circadian system
• Control lighting intervention
Lighting intervention designed to have no impact on the circadian system

Locations

Country	Name	City	State
United States	Light and Health Research Center	Menands	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 22 weeks
Secondary	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.	up to 22 weeks
Secondary	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.	up to 22 weeks