Sleep Interventions and Neurocognitive Outcomes

NCT05987007 | Not Yet Recruiting FDA Device

• 1 other identifier: 8443
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amnestic Mild Cognitive Impairment; Sleep Disturbance

Keywords

Alzheimer's Disease; Slow-Wave Activity; Older Adults; Amnestic Mild Cognitive Impairment; Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Insomnia Severity Index

  Baseline, Week 9, Week 24

• N3 sleep stage ("slow-wave sleep")

  Baseline, Week 9, Week 24

• SubjectiveTotal Sleep Time

  Baseline, Week 9, Week 24

• Objective Total Sleep Time

  Baseline, Week 9, Week 24

• Subjective Wake After Sleep Onset

  Baseline, Week 9, Week 24

Study Arms (2)

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.

Behavioral: Cognitive behavioral therapy for insomnia

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.

Device: Acoustic slow-wave activity enhancement

Interventions

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.

Cognitive Behavioral Therapy for Insomnia

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.

Acoustic Slow-Wave Activity Enhancement

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder
• 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.

Sponsors & Collaborators

• Columbia University: collaborator
• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Parasomnias; Alzheimer Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hyun Kim, PhD

  Columbia University/ New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Kim, PhD

CONTACT

646-774-8459; HK3141@cumc.columbia.edu

Terry E Goldberg, PhD

CONTACT

646-774-5215; teg2117@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 14, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time of publication of the primary results or within 9 months of database lock, whichever comes first.
• 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.

Locations

US (1)