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

NCT05519137 | Completed

• 1 other identifier: STUDY-20-01772
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD)

  up to 22 weeks

• Sleep efficiency measured by actigraphy

  up to 22 weeks

Study Arms (2)

Active lighting intervention then Control lighting condition

ACTIVE COMPARATOR

Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.

Device: Active lighting intervention; Device: Control lighting intervention

Control lighting condition then Active light intervention

ACTIVE COMPARATOR

Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition.

Device: Active lighting intervention; Device: Control lighting intervention

Interventions

Active lighting intervention DEVICE

Lighting intervention designed to impact the circadian system

Active lighting intervention then Control lighting condition; Control lighting condition then Active light intervention

Control lighting intervention DEVICE

Lighting intervention designed to have no impact on the circadian system

Active lighting intervention then Control lighting condition; Control lighting condition then Active light intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
• a score \>5 on the PSQI.

You may not qualify if:

• \- use of sleep medication

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Light and Health Research Center

Menands, New York, 12204, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mariana Figueiro, PhD

  Mount Sinai Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will randomly be assigned to initially receive the active or control lighting intervention

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: January 6, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)