Sleep Interventions and Neurocognitive Outcomes

Sleep Disturbance Clinical Trial

Official title:

Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05987007
• Other study ID #: 8443
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: New York State Psychiatric Institute
• Contact: Hyun Kim, PhD
• Phone: 646-774-8459
• Email: HK3141[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amnestic Mild Cognitive Impairment
• Cognitive Dysfunction
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Device:
• Acoustic slow-wave activity enhancement
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.

Behavioral:
• Cognitive behavioral therapy for insomnia
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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Conners Continuous Performance Test (CPT-3)	Measure of sustained attention and vigilance	Baseline, Week 9, Week 24
Secondary	Insomnia Severity Index	Well-established measure of insomnia symptoms. Scores range from 0-28, and higher scores represent more severe insomnia symptoms.	Baseline, Week 9, Week 24
Secondary	N3 sleep stage ("slow-wave sleep")	N3 sleep duration will be calculated using Dreem Headband, a sleep assessment device that produces objective sleep measures.	Baseline, Week 9, Week 24
Secondary	SubjectiveTotal Sleep Time	Self-reported sleep duration will be asked as part of the sleep diaries.	Baseline, Week 9, Week 24
Secondary	Objective Total Sleep Time	Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)	Baseline, Week 9, Week 24
Secondary	Subjective Wake After Sleep Onset	Self-reported sleep duration will be asked as part of the sleep diaries.	Baseline, Week 9, Week 24
Secondary	Objective Wake After Sleep Onset	Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)	Baseline, Week 9, Week 24