SleepNCT03256539
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
A study testing Sleep intervention in people with Sleep and Alzheimer Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sleep, Alzheimer Disease, Cognitive Impairment
- What is being tested?
- Sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 31 Jan 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
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years old
- Memory complaints verified by an informant
- Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
- General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
- No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
- Adequate visual and auditory acuity to allow neuropsychological testing
- Meets International Classification of Sleep Disorders-2nd edition (ICSD-2) criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping
Who cannot join
- Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma
- Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), such as major depression, bipolar disorder, schizophrenia and other psychotic features
- Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
- History of alcohol or substance abuse within the past 2 years
- Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.
- Conditions
- Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT
- Being tested
- Sleep intervention, Placebo intervention
- 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.
Sleep interventionBehavioural
Behavioral sleep intervention program
Placebo interventionBehavioural
Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention | Experimental | Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT) Receives: Behavioral: Sleep intervention |
| Placebo intervention | Placebo comparator | Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration). Receives: Behavioral: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled to the Study
Measured: Up to 24 weeks following study initiation
Number of Participants That Complete the Study
Measured: Through study completion, up to 34 weeks
Secondary outcomes (2)
Sleep as Assessed by Actigraphy
Week-long measurement using wrist actigraphy
Measured: Through study completion, up to 34 weeks
Cognitive Function Assessed by Standard Neurocognitive Battery
Measured: Through study completion, up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start12 Aug 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Unexpected closure of study components -- the digital intervention (CBT-I) was no longer accessible, and alternatives were not feasible.
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 SleepStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Yue Leng, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256539
- Sponsor's protocol ID
- 1K99AG056598-01
- Other IDs
- 1K99AG056598-01, R00AG056598
- Status last verified
- Oct 2025
- First submitted
- 8 Aug 2017
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03256539
- Acronym / sponsor ID
- 1K99AG056598-01
- Conditions
- Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected closure of study components -- the digital intervention (CBT-I) was no longer accessible, and alternatives were not feasible.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention | Experimental | Behavioral: Sleep interventionSleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT) |
| Placebo intervention | Placebo comparator | Behavioral: Placebo interventionPlacebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥65 years old
- Memory complaints verified by an informant
- Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
- General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
- No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
Key exclusion criteria (5 listed)
- Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma
- Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), such as major depression, bipolar disorder, schizophrenia and other psychotic features
- Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
- History of alcohol or substance abuse within the past 2 years
- Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
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 |
|---|---|---|
| Sleep interventionBehavioral sleep intervention program | Behavioural | Sleep Intervention |
| Placebo interventionQuasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration) | Behavioural | Placebo intervention |
Primary outcome
Number of Participants Enrolled to the Study
Time frame: Up to 24 weeks following study initiation
Number of Participants That Complete the Study
Time frame: Through study completion, up to 34 weeks
2 secondary outcomes
Sleep as Assessed by Actigraphy
Time frame: Through study completion, up to 34 weeks
Cognitive Function Assessed by Standard Neurocognitive Battery
Time frame: Through study completion, up to 34 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Yue Leng, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep intervention in people with Sleep and Alzheimer Disease, run by University of California, San Francisco 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 7 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: stopped early, as of the sponsor's last update on 14 Nov 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. Some participants in this study may receive a placebo. 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 14 Nov 2025). 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?
Number of Participants Enrolled to the Study (time frame: Up to 24 weeks following study initiation). The study lists 2 primary outcomes in all. 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 Nov 2025.