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NCT Number: NCT05987007

Sleep Interventions and Neurocognitive Outcomes

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Location contact

Hyun Kim, PhD

CONTACT

[email protected]

646-774-8691

Hyun Kim, PhD

PRINCIPAL_INVESTIGATOR

Terry E Goldberg, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Conners Continuous Performance Test (CPT-3)

    Time frame: Baseline, Week 9, Week 24

    Measure of sustained attention and vigilance

Secondary outcomes

  1. 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.

  2. 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.

  3. SubjectiveTotal Sleep Time

    Time frame: Baseline, Week 9, Week 24

    Self-reported sleep duration will be asked as part of the sleep diaries.

  4. Objective Total Sleep Time

    Time frame: Baseline, Week 9, Week 24

    Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)

  5. Subjective Wake After Sleep Onset

    Time frame: Baseline, Week 9, Week 24

    Self-reported sleep duration will be asked as part of the sleep diaries.

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun Kim, PhD

CONTACT

[email protected]

646-774-8459

Terry E Goldberg, PhD

CONTACT

[email protected]

646-774-5215

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University

Registry information

Official study title

Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment

Acronym: SINA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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