Alzheimer's DiseaseNCT05519137
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia
A study testing Active lighting intervention in people with Alzheimer's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Active lighting intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 1 May 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
- a score >5 on the PSQI.
Who cannot join
- use of sleep medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Light and Health Research Center
Menands, New York, 12204
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Active lighting intervention, Control lighting intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active lighting interventionDevice
Lighting intervention designed to impact the circadian system
Control lighting interventionDevice
Lighting intervention designed to have no impact on the circadian system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Active lighting intervention; Device: Control lighting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post intervention (8 weeks)
Secondary outcomes (3)
Depression Screening Utilizing 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. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms.
Measured: Baseline and post intervention (8 weeks)
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.
Measured: Baseline and post intervention (8 weeks)
Sleep Burden Using The Sleep Disorders Inventory (SDI)
Full scale from 0 to 56, with higher score indicating greater sleep disturbance
Measured: Baseline and post intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start6 Jan 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will randomly be assigned to initially receive the active or control lighting intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Mount Sinai Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519137
- Sponsor's protocol ID
- STUDY-20-01772
- Other IDs
- R01AG034157, R44AG060857
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2022
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this data collection occurs in a population with Alzheimer's disease, participants are generally not interested in individual results.