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Sleep Interventions and Neurocognitive Outcomes

Primary Purpose

Sleep Disturbance, Amnestic Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic slow-wave activity enhancement
Cognitive behavioral therapy for insomnia
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring Alzheimer's Disease, Slow-Wave Activity, Older Adults, Amnestic Mild Cognitive Impairment, Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English speaking participants, ages 60-85 years Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE <18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS) Presence of subject memory complains not exclusionary. Presence of subjective memory complaints without objective signs of impairment (T-MMSE, QDRS, LM) would not be considered as the presence of late MCI or dementia, therefore are not exclusionary. Participants with regular and consistent use of sleep medications (sedatives/hypnotic use of >3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation/tapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications). Participants must have capacity to provide informed consent. Have access to stable internet connection. A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant Exclusion Criteria: Diagnosis of stroke or excessive risk of CVD Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc) Untreated diabetes Active treatment of cancer Telephone MMSE score below 22 (Newkirk et al., 2004) and Logical Memory above 11 for subjects with 16 or more years of education, 9 for subjects with 8-15 years of education, and 6 for subjects with 0-7 years of education Presence of sleep disorders other than insomnia (moderate-severe sleep apnea, REM-behavior disorder, restless legs syndrome, circadian rhythm disorder). Mild sleep apnea will not be exclusionary. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder Use of antidepressants with known large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepine, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine. Other medications are allowed during the study and are not exclusionary. Participants taking medications with benzodiazepines properties will be excluded. These include: diazepam, quazepam, estazolam, alprazolam, clorazepate, clorazepate, oxazepam, alprazolam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam. Participants with moderate to severe depression (Geriatric Depression Scale>8) will be excluded from the study and will be encouraged to seek treatment for their symptoms. Participants with moderate depression (GDS 5-8) will be encouraged to return for screening after receiving treatment and seeing improvement in their symptoms. Participants who are unable to provide an informant.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Behavioral Therapy for Insomnia

Acoustic Slow-Wave Activity Enhancement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Conners Continuous Performance Test (CPT-3)
Measure of sustained attention and vigilance

Secondary Outcome Measures

Insomnia Severity Index
Well-established measure of insomnia symptoms. Scores range from 0-28, and higher scores represent more severe insomnia symptoms.
N3 sleep stage ("slow-wave sleep")
N3 sleep duration will be calculated using Dreem Headband, a sleep assessment device that produces objective sleep measures.
SubjectiveTotal Sleep Time
Self-reported sleep duration will be asked as part of the sleep diaries.
Objective Total Sleep Time
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
Subjective Wake After Sleep Onset
Self-reported sleep duration will be asked as part of the sleep diaries.
Objective Wake After Sleep Onset
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)

Full Information

First Posted
May 22, 2023
Last Updated
August 23, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05987007
Brief Title
Sleep Interventions and Neurocognitive Outcomes
Official Title
Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Amnestic Mild Cognitive Impairment
Keywords
Alzheimer's Disease, Slow-Wave Activity, Older Adults, Amnestic Mild Cognitive Impairment, Cognitive Behavioral Therapy for Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for Insomnia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acoustic Slow-Wave Activity Enhancement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acoustic slow-wave activity enhancement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
No Practice Effect (NPE) battery
Description
The total composite score, as well as factor scores (Cognitive Control and Executive Functions, Episodic Memory Consolidation, Verbal Working Memory) will be examined.
Time Frame
Baseline, Week 9, Week 24
Title
Everyday Cognition (ECog)
Description
Total score and subdomains (Everyday Planning, Everyday Organization, Everyday Divided Attention, Everyday Language, Everyday Visuospatial Abilities, Everyday Memory Subdomain scores) will be examined.
Time Frame
Baseline, Week 9, Week 24
Title
Conners Continuous Performance Test (CPT-3)
Description
Measure of sustained attention and vigilance
Time Frame
Baseline, Week 9, Week 24
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Well-established measure of insomnia symptoms. Scores range from 0-28, and higher scores represent more severe insomnia symptoms.
Time Frame
Baseline, Week 9, Week 24
Title
N3 sleep stage ("slow-wave sleep")
Description
N3 sleep duration will be calculated using Dreem Headband, a sleep assessment device that produces objective sleep measures.
Time Frame
Baseline, Week 9, Week 24
Title
SubjectiveTotal Sleep Time
Description
Self-reported sleep duration will be asked as part of the sleep diaries.
Time Frame
Baseline, Week 9, Week 24
Title
Objective Total Sleep Time
Description
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
Time Frame
Baseline, Week 9, Week 24
Title
Subjective Wake After Sleep Onset
Description
Self-reported sleep duration will be asked as part of the sleep diaries.
Time Frame
Baseline, Week 9, Week 24
Title
Objective Wake After Sleep Onset
Description
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
Time Frame
Baseline, Week 9, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking participants, ages 60-85 years Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE <18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS) Presence of subject memory complains not exclusionary. Presence of subjective memory complaints without objective signs of impairment (T-MMSE, QDRS, LM) would not be considered as the presence of late MCI or dementia, therefore are not exclusionary. Participants with regular and consistent use of sleep medications (sedatives/hypnotic use of >3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation/tapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications). Participants must have capacity to provide informed consent. Have access to stable internet connection. A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant Exclusion Criteria: Diagnosis of stroke or excessive risk of CVD Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc) Untreated diabetes Active treatment of cancer Telephone MMSE score below 22 (Newkirk et al., 2004) and Logical Memory above 11 for subjects with 16 or more years of education, 9 for subjects with 8-15 years of education, and 6 for subjects with 0-7 years of education Presence of sleep disorders other than insomnia (moderate-severe sleep apnea, REM-behavior disorder, restless legs syndrome, circadian rhythm disorder). Mild sleep apnea will not be exclusionary. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder Use of antidepressants with known large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepine, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine. Other medications are allowed during the study and are not exclusionary. Participants taking medications with benzodiazepines properties will be excluded. These include: diazepam, quazepam, estazolam, alprazolam, clorazepate, clorazepate, oxazepam, alprazolam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam. Participants with moderate to severe depression (Geriatric Depression Scale>8) will be excluded from the study and will be encouraged to seek treatment for their symptoms. Participants with moderate depression (GDS 5-8) will be encouraged to return for screening after receiving treatment and seeing improvement in their symptoms. Participants who are unable to provide an informant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Kim, PhD
Phone
646-774-8459
Email
HK3141@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Terry E Goldberg, PhD
Phone
646-774-5215
Email
teg2117@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, PhD
Organizational Affiliation
Columbia University/ New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aren Tucker, BA
Phone
646-774-8691
Email
aren.tucker@nyspi.columbia.edu
First Name & Middle Initial & Last Name & Degree
Daniel Cohen, BA
Phone
646-774-7204
Email
daniel.cohen@nyspi.columbia.edu
First Name & Middle Initial & Last Name & Degree
Hyun Kim, PhD
First Name & Middle Initial & Last Name & Degree
Terry E Goldberg, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
At the time of publication of the primary results or within 9 months of database lock, whichever comes first.
IPD Sharing Access Criteria
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.

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Sleep Interventions and Neurocognitive Outcomes

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