SleepPhase 4NCT06009289
Light and Sleep Fragmentation
A Phase 4 study testing Light therapy in people with Sleep and Mild Cognitive Impairment, run by Stanford University at 1 site in United States.
Trial summary
This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Mild Cognitive Impairment, Mood Disorders
- What is being tested?
- Light therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Mild Cognitive Impairment
- Age >65
Who cannot join
- Severe depression
- Unstable psychiatric or medical disease
- Acute infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renske Lok, PhD contact
United States1 site
Stanford University
Redwood City, California, 94063
Renske Lok, PhD, rlok@stanford.edu
About this study
Official title: Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults
This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.
- Conditions
- Sleep, Mild Cognitive Impairment, Mood Disorders
- Being tested
- Light therapy
- Medical subject headings
- Cognitive Dysfunction, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyBehavioural
One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | One hour of daily bright light exposure beginning one hour after wake time. Receives: Behavioral: Light therapy |
| Stepped care | Experimental | One hour of daily bright light exposure in the afternoon Receives: Behavioral: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep fragmentation
24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation
Measured: 4 weeks
Secondary outcomes (2)
Cognition
Performance on the WAIS-4
Measured: 6 months
Mood
Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009289
- Sponsor's protocol ID
- IRB-71788
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults
- ClinicalTrials.gov ID
- NCT06009289
- Acronym / sponsor ID
- IRB-71788
- Conditions
- Sleep, Mild Cognitive Impairment, Mood Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 24 Aug 2023 (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.
This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Light therapyOne hour of daily bright light exposure beginning one hour after wake time. |
| Stepped care | Experimental | Behavioral: Light therapyOne hour of daily bright light exposure in the afternoon |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Mild Cognitive Impairment
- Age >65
Key exclusion criteria (3 listed)
- Severe depression
- Unstable psychiatric or medical disease
- Acute infection
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 therapyOne hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor | Behavioural | Standard of care, Stepped care |
Primary outcome
Sleep fragmentation
Time frame: 4 weeks
24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation
2 secondary outcomes
Cognition
Time frame: 6 months
Mood
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Yes. After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github
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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.
Renske Lok, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Light therapy in people with Sleep and Mild Cognitive Impairment, run by Stanford University 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 3 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: opening soon, as of the sponsor's last update on 25 Aug 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renske Lok, PhD (rlok@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep fragmentation (time frame: 4 weeks). 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 25 Aug 2023.