Alzheimer's DiseaseNCT06356337
A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1
A study testing Light goggles and Daily reminder test message in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the relationship between reminder messages sent via text and compliance with a daily morning light intervention designed to advance the circadian clock. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Light goggles and Daily reminder test message
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults over the age of 55
- score of 25 or greater on MoCA
Who cannot join
- Severe sleep apnea
- restless leg syndrome
- obstructing cataracts
- macular degeneration
- diabetic retinopathy
- glaucoma
- use of sleep medications
- brain disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Light and Health Research Center
Menands, New York, 12204
About this study
Official title: Light Exposure Tracker in Alzheimer's Disease.
The purpose of this research study is to investigate the relationship between reminder messages sent via text and compliance with a daily morning light intervention designed to advance the circadian clock. Twenty healthy adults will be recruited to participate in a randomized, cross-over study where daily messages are, or are not, provided to remind participants to carry out the intervention.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- Light goggles, Daily reminder test message
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light gogglesDevice
Green light goggles worn for 1 hour each morning for two weeks
Daily reminder test messageBehavioural
Participants will receive daily text message reminding them to use light goggles each morning
| Study group | Role | What they receive |
|---|---|---|
| Light Googles plus reminder text messages | Active comparator | Participants use green light goggles for one hour each morning for two consecutive weeks and also receive a daily text message reminding them to wear the light goggles Receives: Device: Light goggles; Behavioral: Daily reminder test message |
| Light Goggles alone | Experimental | Participants use green light goggles for one hour each morning for two consecutive weeks Receives: Device: Light goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva samples for melatonin levels
Serial saliva samples will be collected to calculate dim light melatonin onset.
Measured: Baseline and 2-weeks post-intervention for each Arm
Secondary outcomes (2)
Light exposure using the Speck
The Speck light meter will be used to collect overall light exposure.The Speck light meter uses a photosensor to measure the amount of light study participants are exposed to each day.
Measured: worn all 12 study weeks
Sleep time using actigraphy
Sleep time will be calculated from the actigraph. The wrist actigraph measures activity during the day and how well you sleep at night. The actigraph software will calculate the amount of time spent in bed sleeping.
Measured: worn all 12 study weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start22 Feb 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Ichan School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356337
- Sponsor's protocol ID
- STUDY-22-01199
- Status last verified
- Oct 2025
- First submitted
- 4 Apr 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: overall study results will be shared not individual.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Exposure Tracker in Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT06356337
- Acronym / sponsor ID
- STUDY-22-01199
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate the relationship between reminder messages sent via text and compliance with a daily morning light intervention designed to advance the circadian clock. Twenty healthy adults will be recruited to participate in a randomized, cross-over study where daily messages are, or are not, provided to remind participants to carry out the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Googles plus reminder text messages | Active comparator | Device: Light goggles, Behavioral: Daily reminder test messageParticipants use green light goggles for one hour each morning for two consecutive weeks and also receive a daily text message reminding them to wear the light goggles |
| Light Goggles alone | Experimental | Device: Light gogglesParticipants use green light goggles for one hour each morning for two consecutive weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adults over the age of 55
- score of 25 or greater on MoCA
Key exclusion criteria (8 listed)
- Severe sleep apnea
- restless leg syndrome
- obstructing cataracts
- macular degeneration
- diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light gogglesGreen light goggles worn for 1 hour each morning for two weeks | Device | Light Goggles alone, Light Googles plus reminder text messages |
| Daily reminder test messageParticipants will receive daily text message reminding them to use light goggles each morning | Behavioural | Light Googles plus reminder text messages |
Primary outcome
Saliva samples for melatonin levels
Time frame: Baseline and 2-weeks post-intervention for each Arm
Serial saliva samples will be collected to calculate dim light melatonin onset.
2 secondary outcomes
Light exposure using the Speck
Time frame: worn all 12 study weeks
Sleep time using actigraphy
Time frame: worn all 12 study weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No. overall study results will be shared not individual.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Figueiro, PhD principal investigator
Ichan School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light goggles and Daily reminder test message in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 1 site 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 2 inclusion and 8 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 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Saliva samples for melatonin levels (time frame: Baseline and 2-weeks post-intervention for each Arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.