- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987007
Sleep Interventions and Neurocognitive Outcomes
Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyun Kim, PhD
- Phone Number: 646-774-8459
- Email: HK3141@cumc.columbia.edu
Study Contact Backup
- Name: Terry E Goldberg, PhD
- Phone Number: 646-774-5215
- Email: teg2117@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
Contact:
- Aren Tucker, BA
- Phone Number: 646-774-8691
- Email: aren.tucker@nyspi.columbia.edu
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Contact:
- Daniel Cohen, BA
- Phone Number: 646-774-7204
- Email: daniel.cohen@nyspi.columbia.edu
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Principal Investigator:
- Hyun Kim, PhD
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Sub-Investigator:
- Terry E Goldberg, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive Behavioral Therapy for Insomnia
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.
|
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.
|
Active Comparator: Acoustic Slow-Wave Activity Enhancement
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
No Practice Effect (NPE) battery
Time Frame: Baseline, Week 9, Week 24
|
The total composite score, as well as factor scores (Cognitive Control and Executive Functions, Episodic Memory Consolidation, Verbal Working Memory) will be examined.
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Baseline, Week 9, Week 24
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Everyday Cognition (ECog)
Time Frame: Baseline, Week 9, Week 24
|
Total score and subdomains (Everyday Planning, Everyday Organization, Everyday Divided Attention, Everyday Language, Everyday Visuospatial Abilities, Everyday Memory Subdomain scores) will be examined.
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Baseline, Week 9, Week 24
|
Conners Continuous Performance Test (CPT-3)
Time Frame: Baseline, Week 9, Week 24
|
Measure of sustained attention and vigilance
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Baseline, Week 9, Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index
Time Frame: Baseline, Week 9, Week 24
|
Well-established measure of insomnia symptoms.
Scores range from 0-28, and higher scores represent more severe insomnia symptoms.
|
Baseline, Week 9, Week 24
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N3 sleep stage ("slow-wave sleep")
Time Frame: Baseline, Week 9, Week 24
|
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
Time Frame: Baseline, Week 9, Week 24
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Self-reported sleep duration will be asked as part of the sleep diaries.
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Baseline, Week 9, Week 24
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Objective Total Sleep Time
Time Frame: Baseline, Week 9, Week 24
|
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
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Baseline, Week 9, Week 24
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Subjective Wake After Sleep Onset
Time Frame: Baseline, Week 9, Week 24
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Self-reported sleep duration will be asked as part of the sleep diaries.
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Baseline, Week 9, Week 24
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Objective Wake After Sleep Onset
Time Frame: Baseline, Week 9, Week 24
|
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
|
Baseline, Week 9, Week 24
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hyun Kim, PhD, Columbia University/ New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8443 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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