Amnestic Mild Cognitive Impairment - aMCITASSLENCT07911826
Targeting Sleep and Slow-Wave Activity to Enhance Cognition in MCI
A study testing active intervention in people with Amnestic Mild Cognitive Impairment - aMCI and Insomnia, run by New York State Psychiatric Institute.
Trial summary
Study Description As most clinical trials in Alzheimer's disease (AD) have been unsuccessful to date, it has become increasingly crucial to focus on treating earlier stages of the disease. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment - aMCI, Insomnia
- What is being tested?
- active intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking, ages 60-85 years Telephone MMSE (T-MMSE) score of 22 or greater at screening Diagnosis of amnestic MCI, per Logical Memory (LM) delayed recall and QDRS criteria (education-adjusted LM cutoffs; QDRS total ≥1.5 with memory subscore ≥0.5) Presence of sleep disturbance, defined as Insomnia Severity Index (ISI) score ≥8 at baseline Capacity to provide informed consent Access to a stable internet connection Availability of a family member or other informant in regular contact with the participant, willing to serve as an informant (telephone informant acceptable)
Who cannot join
- Diagnosis of stroke or excessive cardiovascular disease risk Neurologic disease, including movement disorders, multiple sclerosis, epilepsy, or traumatic brain injury with loss of consciousness >15 minutes Untreated diabetes Active cancer treatment Telephone MMSE score below 22, or Logical Memory score above education-adjusted cutoffs (indicating no cognitive impairment) Sleep disorders other than insomnia (moderate-to-severe sleep apnea, REM behavior disorder, restless legs syndrome, circadian rhythm disorder); mild sleep apnea is not exclusionary Current DSM-5 diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder Use of sleep aids (prescription or OTC) within the past 14 days Use of antidepressants with significant anticholinergic properties (e.g., amitriptyline, doxepin, mirtazapine - full list in protocol) Use of benzodiazepines (e.g., diazepam, lorazepam, alprazolam - full list in protocol) Moderate-to-severe depression (Geriatric Depression Scale >8) Inability to provide an informant
About this study
Study Description As most clinical trials in Alzheimer's disease (AD) have been unsuccessful to date, it has become increasingly crucial to focus on treating earlier stages of the disease. Compelling evidence indicates that sleep disruption is associated with accumulation of Alzheimer's biomarkers, including amyloid-beta (Aβ) and tau pathology. Slow-wave activity (SWA) during sleep is particularly important for the clearance of Aβ and sleep-dependent memory consolidation, and sleep disturbance could reduce the amount of time spent in slow-wave sleep. Together, these findings suggest that treating sleep disruption in older adults may help reduce the level of adverse brain aging.
The goal of this study is to better understand the effect of sleep interventions on improving sleep and building cognitive resilience in older adults with amnestic mild cognitive impairment (aMCI), and to assess the feasibility of relevant study protocols. Fifty older adults (ages 60-85) with aMCI and sleep disturbance (Insomnia Severity Index score of 8 or greater) will be randomized 1:1 to one of two treatment arms: Cognitive Behavioral Therapy for Insomnia only (CBT-I + Sham), or CBT-I combined with acoustic slow-wave activity enhancement (CBT-I + SWAE). CBT-I is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through non-invasive earbuds (Smartbuds, NextSense Inc.) that detect and amplify endogenous slow-wave activity using acoustic pulses during sleep.
Read more
Each participant will complete 3 visits over approximately 6 months: a baseline visit, a post-treatment visit (approximately 12 weeks after baseline), and a 6-month follow-up visit. Group differences will be compared on changes in cognitive performance and plasma biomarkers of AD (phosphorylated tau [pTau-217]) across these time points. The study will also explore potential mechanisms behind the relationship between sleep and cognition/biomarkers by investigating a range of objectively measured sleep metrics (e.g., sleep architecture, sleep duration, arousals) along with depressive symptoms.
Hypotheses:
CBT-I will be associated with more favorable outcomes (i.e., less decline or greater improvement) in frontal network functioning (sustained attention/target detection, executive functions), while SWAE will be associated with better outcomes in measures of episodic memory (word-list learning and story recall). Improvements in total sleep time and insomnia symptoms at 8 weeks are hypothesized to mediate the relationship between CBT-I and performance on attention and executive functions over 6 months, while improvements in slow-wave non-rapid eye movement (NREM) sleep at 12 weeks are hypothesized to mediate the relationship between SWAE and episodic memory measures. Additionally, CBT-I is hypothesized to be associated with increased scores on the Visuospatial Abilities, Planning, Organization, and Divided Attention subscales of the Everyday Cognition (ECog) questionnaire after 6 months, while SWAE is hypothesized to be associated with a significant increase in the Everyday Memory subscale.
Objectives:
Aim 1: To determine if CBT-I and SWAE have different neuropsychological outcomes in aMCI.
Aim 2: To examine the impact of sleep treatments on cognitively mediated everyday functioning.
Exploratory Aim: To assess whether CBT-I and/or SWAE are associated with changes in plasma pTau and whether pTau moderates the association between sleep and cognition.
Results from this study will determine whether sleep interventions can build brain and cognitive resilience in the context of aging, and will inform the design of a future, larger-scale R01 study rigorously examining the association between targeted sleep modifications and markers of AD pathophysiology as a potentially modifiable risk factor for dementia.
- Being tested
- active intervention, Control Intervention
- Keywords
- CBT-I, Cognitive Behavioral Therapy for Insomnia, Slow-Wave Activity Enhancement, Sleep, Alzheimer's Disease prevention, Amnestic Mild Cognitive Impairment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active interventionDevice
slow wave sleep enhancement vi NextSense Smart buds
Control InterventionDevice
Sham condition (device worn without active enhancement)
| Study group | Role | What they receive |
|---|---|---|
| Sham Condition | Sham comparator | This sham condition includes the device being worn without any active pink noise engagement Receives: Device: Control Intervention |
| Slow Wave Enhancement | Active comparator | Slow wave enhancement via NextSense SmartBuds Receives: Device: active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention/Executive Function Composite Score
Composite of performance on the No Practice Effect (NPE) test battery measures of frontal network functioning, including N-back (target detection/working memory), Letter-Number Span (executive function), Symbol Coding (processing speed), and Verbal Fluency. Change reflects Hypothesis 1a (CBT-I predicted to show greater improvement on this domain).
Measured: 8 weeks and 6 months
Secondary outcomes (1)
Change in Everyday Cognition (ECog) Subscale Scores
Informant-rated change on ECog subscales, including Everyday Memory, Visuospatial Abilities, Planning, Organization, and Divided Attention, assessing cognitively mediated everyday functioning (Aim 2/Hypothesis 2).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amnestic Mild Cognitive Impairment - aMCIStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Hyun "Monica" Kim, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911826
- Sponsor's protocol ID
- NYSPI2026-213
- Other IDs
- 26AARGA-1567554
- Acronym
- TASSLE
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Kim H, Zhu X, Zhao Y, Bell SA, Gehrman PR, Cohen D, Devanand DP, Goldberg TE, Lee S; Alzheimer's Disease Neuroimaging Initiative. Resting-state functional connectivity changes in older adults with sleep disturbance and the role of amyloid burden. Mol Psychiatry. 2023 Oct;28(10):4399-4406. doi: 10.1038/s41380-023-02214-9. Epub 2023 Aug 18.
PubMed 37596355Papalambros NA, Santostasi G, Malkani RG, Braun R, Weintraub S, Paller KA, Zee PC. Acoustic Enhancement of Sleep Slow Oscillations and Concomitant Memory Improvement in Older Adults. Front Hum Neurosci. 2017 Mar 8;11:109. doi: 10.3389/fnhum.2017.00109. eCollection 2017.
PubMed 28337134Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8.
PubMed 29220627
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Sleep and Slow-Wave Activity to Enhance Cognition in MCI
- ClinicalTrials.gov ID
- NCT07911826
- Acronym / sponsor ID
- TASSLE / NYSPI2026-213
- Keywords
- CBT-I, Cognitive Behavioral Therapy for Insomnia, Slow-Wave Activity Enhancement, Sleep, Alzheimer's Disease prevention, Amnestic Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Nov 2026 (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.
Study Description As most clinical trials in Alzheimer's disease (AD) have been unsuccessful to date, it has become increasingly crucial to focus on treating earlier stages of the disease. Compelling evidence indicates that sleep disruption is associated with accumulation of Alzheimer's biomarkers, including amyloid-beta (Aβ) and tau pathology. Slow-wave activity (SWA) during sleep is particularly important for the clearance of Aβ and sleep-dependent memory consolidation, and sleep disturbance could reduce the amount of time spent in slow-wave sleep. Together, these findings suggest that treating sleep disruption in older adults may help reduce the level of adverse brain aging.
The goal of this study is to better understand the effect of sleep interventions on improving sleep and building cognitive resilience in older adults with amnestic mild cognitive impairment (aMCI), and to assess the feasibility of relevant study protocols. Fifty older adults (ages 60-85) with aMCI and sleep disturbance (Insomnia Severity Index score of 8 or greater) will be randomized 1:1 to one of two treatment arms: Cognitive Behavioral Therapy for Insomnia only (CBT-I + Sham), or CBT-I combined with acoustic slow-wave activity enhancement (CBT-I + SWAE). CBT-I is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through non-invasive earbuds (Smartbuds, NextSense Inc.) that detect and amplify endogenous slow-wave activity using acoustic pulses during sleep.
Each participant will complete 3 visits over approximately 6 months: a baseline visit, a post-treatment visit (approximately 12 weeks after baseline), and a 6-month follow-up visit. Group differences will be compared on changes in cognitive performance and plasma biomarkers of AD (phosphorylated tau [pTau-217]) across these time points. The study will also explore potential mechanisms behind the relationship between sleep and cognition/biomarkers by investigating a range of objectively measured sleep metrics (e.g., sleep architecture, sleep duration, arousals) along with depressive symptoms.
Hypotheses:
CBT-I will be associated with more favorable outcomes (i.e., less decline or greater improvement) in frontal network functioning (sustained attention/target detection, executive functions), while SWAE will be associated with better outcomes in measures of episodic memory (word-list learning and story recall). Improvements in total sleep time and insomnia symptoms at 8 weeks are hypothesized to mediate the relationship between CBT-I and performance on attention and executive functions over 6 months, while improvements in slow-wave non-rapid eye movement (NREM) sleep at 12 weeks are hypothesized to mediate the relationship between SWAE and episodic memory measures. Additionally, CBT-I is hypothesized to be associated with increased scores on the Visuospatial Abilities, Planning, Organization, and Divided Attention subscales of the Everyday Cognition (ECog) questionnaire after 6 months, while SWAE is hypothesized to be associated with a significant increase in the Everyday Memory subscale.
Objectives:
Aim 1: To determine if CBT-I and SWAE have different neuropsychological outcomes in aMCI.
Aim 2: To examine the impact of sleep treatments on cognitively mediated everyday functioning.
Exploratory Aim: To assess whether CBT-I and/or SWAE are associated with changes in plasma pTau and whether pTau moderates the association between sleep and cognition.
Results from this study will determine whether sleep interventions can build brain and cognitive resilience in the context of aging, and will inform the design of a future, larger-scale R01 study rigorously examining the association between targeted sleep modifications and markers of AD pathophysiology as a potentially modifiable risk factor for dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Condition | Sham comparator | Device: Control InterventionThis sham condition includes the device being worn without any active pink noise engagement |
| Slow Wave Enhancement | Active comparator | Device: active interventionSlow wave enhancement via NextSense SmartBuds |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking, ages 60-85 years Telephone MMSE (T-MMSE) score of 22 or greater at screening Diagnosis of amnestic MCI, per Logical Memory (LM) delayed recall and QDRS criteria (education-adjusted LM cutoffs; QDRS total ≥1.5 with memory subscore ≥0.5) Presence of sleep disturbance, defined as Insomnia Severity Index (ISI) score ≥8 at baseline Capacity to provide informed consent Access to a stable internet connection Availability of a family member or other informant in regular contact with the participant, willing to serve as an informant (telephone informant acceptable)
Key exclusion criteria (1 listed)
- Diagnosis of stroke or excessive cardiovascular disease risk Neurologic disease, including movement disorders, multiple sclerosis, epilepsy, or traumatic brain injury with loss of consciousness >15 minutes Untreated diabetes Active cancer treatment Telephone MMSE score below 22, or Logical Memory score above education-adjusted cutoffs (indicating no cognitive impairment) Sleep disorders other than insomnia (moderate-to-severe sleep apnea, REM behavior disorder, restless legs syndrome, circadian rhythm disorder); mild sleep apnea is not exclusionary Current DSM-5 diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder Use of sleep aids (prescription or OTC) within the past 14 days Use of antidepressants with significant anticholinergic properties (e.g., amitriptyline, doxepin, mirtazapine - full list in protocol) Use of benzodiazepines (e.g., diazepam, lorazepam, alprazolam - full list in protocol) Moderate-to-severe depression (Geriatric Depression Scale >8) Inability to provide an informant
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 |
|---|---|---|
| active interventionslow wave sleep enhancement vi NextSense Smart buds | Device | Slow Wave Enhancement |
| Control InterventionSham condition (device worn without active enhancement) | Device | Sham Condition |
Primary outcome
Change in Attention/Executive Function Composite Score
Time frame: 8 weeks and 6 months
Composite of performance on the No Practice Effect (NPE) test battery measures of frontal network functioning, including N-back (target detection/working memory), Letter-Number Span (executive function), Symbol Coding (processing speed), and Verbal Fluency. Change reflects Hypothesis 1a (CBT-I predicted to show greater improvement on this domain).
1 secondary outcome
Change in Everyday Cognition (ECog) Subscale Scores
Time frame: Baseline and 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 3 Nov 2026.
- Background: PubMed 37596355Kim H, Zhu X, Zhao Y, Bell SA, Gehrman PR, Cohen D, Devanand DP, Goldberg TE, Lee S; Alzheimer's Disease Neuroimaging Initiative. Resting-state functional connectivity changes in older adults with sleep disturbance and the role of amyloid burden. Mol Psychiatry. 2023 Oct;28(10):4399-4406. doi: 10.1038/s41380-023-02214-9. Epub 2023 Aug 18.
- Background: PubMed 28337134Papalambros NA, Santostasi G, Malkani RG, Braun R, Weintraub S, Paller KA, Zee PC. Acoustic Enhancement of Sleep Slow Oscillations and Concomitant Memory Improvement in Older Adults. Front Hum Neurosci. 2017 Mar 8;11:109. doi: 10.3389/fnhum.2017.00109. eCollection 2017.
- Background: PubMed 29220627Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing active intervention in people with Amnestic Mild Cognitive Impairment - aMCI and Insomnia, run by New York State Psychiatric Institute.
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 1 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
Change in Attention/Executive Function Composite Score (time frame: 8 weeks and 6 months). 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 NCT07911826, which also lists 3 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 3 Nov 2026.