Clinical trial NCT05987007: Sleep Interventions and Neurocognitive Outcomes
Official title: Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Amnestic Mild Cognitive Impairment
Keywords: Alzheimer's Disease
Slow-Wave Activity
Older Adults
Amnestic Mild Cognitive Impairment
Cognitive Behavioral Therapy for Insomnia
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. English speaking participants, ages 60-85 years
2. 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.
3. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)
4. 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.
5. 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.
6. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).
7. Participants must have capacity to provide informed consent.
8. Have access to stable internet connection.
9. 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:

1. Diagnosis of stroke or excessive risk of CVD
2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc)
3. Untreated diabetes
4. Active treatment of cancer
5. 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
6. 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.
7. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder
8. 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.
9. 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.
10. 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.
11. Participants who are unable to provide an informant.

Primary outcomes:
measure: No Practice Effect (NPE) battery
timeFrame: Baseline, Week 9, Week 24
measure: Everyday Cognition (ECog)
timeFrame: Baseline, Week 9, Week 24
measure: Conners Continuous Performance Test (CPT-3)
timeFrame: Baseline, Week 9, Week 24
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline, Week 9, Week 24
measure: N3 sleep stage ("slow-wave sleep")
timeFrame: Baseline, Week 9, Week 24
measure: SubjectiveTotal Sleep Time
timeFrame: Baseline, Week 9, Week 24
measure: Objective Total Sleep Time
timeFrame: Baseline, Week 9, Week 24
measure: Subjective Wake After Sleep Onset
timeFrame: Baseline, Week 9, Week 24
measure: Objective Wake After Sleep Onset
timeFrame: Baseline, Week 9, Week 24
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University/ New York State Psychiatric Institute
name: Hyun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: