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Sleep DisturbancesNCT01816152

Methodology Issues in a Tailored Light Treatment for Persons With Dementia

A study testing High Active intervention, Inactive intervention and Mid Level Active Intervention in people with Sleep Disturbances and Depression, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep Disturbances, Depression
What is being tested?
High Active intervention, Inactive intervention and Mid Level Active Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesUnited States
Study dates
1 Jan 2020to 10 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • mild to moderate Alzheimer's disease and related dementia (ADRD)

Who cannot join

  • major organ failure,
  • major illness,
  • history of head injury,
  • hypertension or diabetes,
  • use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Icahn School of Medicine at Mount Sinai

    Albany, New York, 12204

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia

Read the detailed description

In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.

Being tested
High Active intervention, Inactive intervention, Mid Level Active Intervention
Keywords
light treatment, circadian rhythms, sleep, agitation, depression
Medical subject headings
Parasomnias, Depression, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Active interventionOther

    The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.

  • Inactive interventionOther

    The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.

  • Mid Level Active InterventionOther

    The Mid level active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.

Study groups in NCT01816152
Study groupRoleWhat they receive
Participants with DementiaExperimentalAll participants experience a baseline for 1 week and an active intervention for 4 weeks for all 3 conditions (high active intervention, mid level active intervention, and inactive intervention).
Receives: Other: High Active intervention; Other: Inactive intervention; Other: Mid Level Active Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PSQI)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance

    Measured: Change from Baseline (week 0) and intervention (week 4)

  2. Cohen-Mansfield Agitation Inventory (CMAI)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. 29 item instrument, each item scored 1-7. Total range score from 29-203 - a higher score indicates more agitation

    Measured: Change from Baseline (week 0) and intervention (week 4)

  3. Cornell Scale for Depression in Dementia (CSDD) Questionnaire

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score range 0-38. A score greater than 12 indicates depression and a higher score indicates greater depression.

    Measured: Change from Baseline (week 0) and intervention (week 4)

Secondary outcomes (3)

  1. Activity of Daily Living Questionnaire (MDS-ADL)

    Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence.

    Measured: Change from Baseline (week 0) and intervention (week 4)

  2. Circadian Stimulus Dose

    Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. Circadian stimulus (CS) is the amount of light needed to activate the circadian system. The range is 0 to 0.6 the higher the number the greater the CS dose

    Measured: Change from Baseline (week 0) and intervention (week 4)

  3. Sleep Efficiency Score

    Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. Full scale score from 0-100, higher score indicates better efficiency.

    Measured: Change from Baseline (week 0) and intervention (week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2013 (estimated)
  2. Study start1 Jan 2020
  3. Primary completion10 May 2024
  4. Study completion10 May 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816152
Sponsor's protocol ID
GCO 20-4007
Other IDs
7R01AG034157-11
Status last verified
Jun 2026
First submitted
15 Mar 2013
Last updated
27 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Figueiro MG, Hamner R, Higgins P, Hornick T, Rea MS. Field measurements of light exposures and circadian disruption in two populations of older adults. J Alzheimers Dis. 2012;31(4):711-5. doi: 10.3233/JAD-2012-120484.

    PubMed 22699845

  • Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645.

    PubMed 23099814

  • Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.

    PubMed 25246779

  • Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.

    PubMed 31855161

Questions about this trial

What is this clinical trial studying?

A study testing High Active intervention, Inactive intervention and Mid Level Active Intervention in people with Sleep Disturbances and Depression, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: Change from Baseline (week 0) and intervention (week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816152, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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