Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
Not provided
Not provided
Not provided
This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.
This study has the goal of understanding the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults. To implement this, the investigators will conduct a pilot randomized clinical trial in which fifty older adults (with amnestic mild cognitive impairment and sleep disturbance) will be assigned to different treatment groups to test the effects of cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE) over the course of 6 months. CBTI is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through a non-invasive headband that detects and amplifies endogenous slow-wave activity using playing acoustic stimulation ("pink noise"). Group differences will be compared on the changes in cognitive performance and plasma biomarkers of Alzheimer's disease (phosphorylated tau). The investigators 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 APOE genotype and depressive symptoms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Active Comparator | Participants assigned to the CBTI treatment group will receive 8 weeks of weekly telehealth sessions with a masters-level therapist. Each session is approximately 50 minutes in duration. |
|
| Acoustic Slow-Wave Activity Enhancement | Active Comparator | Participants assigned to the SWAE group will be instructed to use the Dreem2 headband at least four nights out of seven nights of the week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic slow-wave activity enhancement | Device | The acoustic enhancement of slow-wave activity will be conducted using the Dreem2 headband. This device utilizes five dry-EEG electrodes (O1, O2, FpZ, F7, and F8), a 3D accelerometer, and a pulse oximeter to detect slow-wave activity and generates acoustic stimulation of slow-waves to augment slow-wave sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| No Practice Effect (NPE) battery | The total composite score, as well as factor scores (Cognitive Control and Executive Functions, Episodic Memory Consolidation, Verbal Working Memory) will be examined. | Baseline, Week 9, Week 24 |
| Everyday Cognition (ECog) | Total score and subdomains (Everyday Planning, Everyday Organization, Everyday Divided Attention, Everyday Language, Everyday Visuospatial Abilities, Everyday Memory Subdomain scores) will be examined. | Baseline, Week 9, Week 24 |
| Conners Continuous Performance Test (CPT-3) | Measure of sustained attention and vigilance | Baseline, Week 9, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Well-established measure of insomnia symptoms. Scores range from 0-28, and higher scores represent more severe insomnia symptoms. | Baseline, Week 9, Week 24 |
| N3 sleep stage ("slow-wave sleep") |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Kim, PhD | Contact | 646-774-8459 | HK3141@cumc.columbia.edu | |
| Terry E Goldberg, PhD | Contact | 646-774-5215 | teg2117@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Kim, PhD | Columbia University/ New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
All subject data will be de-identified. Clinical trial data with accompanying metadata, and bio-samples (if relevant) will be housed at GAAIN, a publicly available data repository funded and maintained by the Alzheimer's Association and will comply with all standard practices for data management. As defined within PAR-21-359 for early-stage clinical trials, all study data, including post-randomization trial data, raw and processed primary data, and remaining bio-samples (if relevant), will be made available to the scientific community at the time of publication of the primary results or within 9 months of database lock, whichever comes first. We will provide the necessary documentation, metadata, and supporting information to ensure proper understanding and utilization of the shared data.
At the time of publication of the primary results or within 9 months of database lock, whichever comes first.
Requests are made and detailed using a 2-page request form with the following sections:
Significance; Data Requested; Methodologies; Statistical Plan; Alignment with study goals.
Data request review criterion:
The review criteria will include the significance of the request; use of appropriate methodologies; absence of conflict with other on-going data analysis by our group or outside investigators already conducting similar studies; and alignment with the basic goal of the grant (cognitive enhancement in aMCI and understanding its mechanisms).
We will provide progress reports to the NIH on data sharing activities, including the number of data access requests received, approved, and denied, as well as updates on the utilization and impact of the shared data.
Not provided
Not provided
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D003704 | Dementia |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cognitive behavioral therapy for insomnia | Behavioral | Cognitive behavioral therapy for insomnia (CBTI) is a well-established first-line or complimentary treatment for insomnia which consists of cognitive and behavioral modifications, including addressing maladaptive sleep-related behaviors, controlling sleep environment, and limiting time spent in bed. |
|
N3 sleep duration will be calculated using Dreem Headband, a sleep assessment device that produces objective sleep measures.
| Baseline, Week 9, Week 24 |
| SubjectiveTotal Sleep Time | Self-reported sleep duration will be asked as part of the sleep diaries. | Baseline, Week 9, Week 24 |
| Objective Total Sleep Time | Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2) | Baseline, Week 9, Week 24 |
| Subjective Wake After Sleep Onset | Self-reported sleep duration will be asked as part of the sleep diaries. | Baseline, Week 9, Week 24 |
| Objective Wake After Sleep Onset | Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2) | Baseline, Week 9, Week 24 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |