NCT05519137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

August 25, 2022

Results QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI)

    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.

    Baseline and post intervention (8 weeks)

Secondary Outcomes (3)

  • Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD)

    Baseline and post intervention (8 weeks)

  • Sleep Efficiency Measured by Actigraphy

    Baseline and post intervention (8 weeks)

  • Sleep Burden Using The Sleep Disorders Inventory (SDI)

    Baseline and post intervention (8 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 interventionDevice: 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 interventionDevice: Control lighting intervention

Interventions

Active lighting interventionDEVICE

Lighting intervention designed to impact the circadian system

Active lighting intervention then Control lighting conditionControl lighting condition then Active light intervention
Control lighting interventionDEVICE

Lighting intervention designed to have no impact on the circadian system

Active lighting intervention then Control lighting conditionControl lighting condition then Active light intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Light and Health Research Center

Menands, New York, 12204, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Mariana Figueiro, PhD
Organization
Icahn School of Medicine at Mount Sinai
mariana.figueiro@mountsinai.org
(518) 366-9306

Study Officials

  • Mariana Figueiro, PhD

    Mount Sinai Icahn School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will randomly be assigned to initially receive the active or control lighting intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

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

July 30, 2026

Results First Posted

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Since this data collection occurs in a population with Alzheimer's disease, participants are generally not interested in individual results.

Locations

US(1)