Sleep Interventions and Neurocognitive Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNew York State Psychiatric Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acoustic slow-wave activity enhancement
DeviceThe acoustic enhancement of slow-wave activity will be conducted using the NextSense Smartbuds. These devices utilize ear-EEG technology with three ear-EEG chenille sea triaxial accelerometer to detect changes in cortical activity associated with sleep stages. The devices generate acoustic pulses during the upstate of the endogenous slow-waves to amplify SWS.
Cognitive behavioral therapy for insomnia
BehavioralCognitive 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral Therapy for InsomniaActive comparator 1 intervention
Group B: Acoustic Slow-Wave Activity EnhancementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Week 9, Week 242
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.
Time frame
Baseline, Week 9, Week 243
Conners Continuous Performance Test (CPT-3)
Measure of sustained attention and vigilance
Time frame
Baseline, Week 9, Week 24Secondary outcomes
1
Insomnia Severity Index
Well-established measure of insomnia symptoms. Scores range from 0-28, and higher scores represent more severe insomnia symptoms.
Time frame
Baseline, Week 9, Week 242
N3 sleep stage ("slow-wave sleep")
N3 sleep duration will be calculated using Dreem Headband, a sleep assessment device that produces objective sleep measures.
Time frame
Baseline, Week 9, Week 243
SubjectiveTotal Sleep Time
Self-reported sleep duration will be asked as part of the sleep diaries.
Time frame
Baseline, Week 9, Week 244
Objective Total Sleep Time
Objective sleep duration will be measured via sleep monitoring device (Dreem Headband 2)
Time frame
Baseline, Week 9, Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov
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