Enhanced CBTi for Older Adult Sleep and Cognition (R44)

A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk

This randomized clinical trial on 60+ aged and independent-living healthy individuals with symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).

Study Overview

• Status: Completed
• Conditions: Insomnia; Alzheimers Disease Related Dementias
• Intervention / Treatment: Combination product: CBTi with Application; Behavioral: CBTi; Behavioral: Sleep Hygiene Education

Detailed Description

Telehealth-delivered enhanced CBTi (integrated with a sleep diary app, a therapist dashboard, and data from IoT devices) will be compared to standard telehealth CBTi and to usual treatment with sleep hygiene education. The investigators will determine effects on insomnia (primary outcome) and on clinical sleep metrics (secondary outcome), among other outcomes including cognitive performance, blood biomarkers of ADRD, and therapeutic adherence.

After screening consent and qualification, informed consent, and adherence evaluation with ambulatory devices (1wk), study participants are pseudo-randomized into one of 3 study arms (2:2:1, Enhanced CBTi : Standard CBTi : Sleep Hygiene). The living space of participants is equipped with IoT data collection devices. Participants take surveys related to sleep, have blood drawn, wear ambulatory devices, complete cognitive evaluations, and interact with nearable living space devices and an iPhone interface during a preparation week leading up to an intake telehealth appointment. Baseline data collection (1wk) occurs. Participants then adhere to behavioral therapy directives prescribed at weekly telehealth sessions with a clinically qualified therapist, take surveys related to sleep, complete cognitive evaluations, wear ambulatory devices, and interact with nearable living space devices and an iPhone interface throughout the study intervention period of 6 weeks. During the final week (coinciding with the 6th intervention week), participants have a second blood draw and return all study equipment/devices at the conclusion of participation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fluent English speaker/reader
• Resident of the state/commonwealth of Pennsylvania for tax purposes
• Ability to complete (sign) own consent form
• Age 60-90 (inclusive, at enrollment)
• Independent Living status (or equivalent; if dwelling in a community living facility)
• Insomnia Severity Index (ISI) screening survey score of >=11
• Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
• Willing to maintain existing physician-directed intervention for issues pertaining to sleep for the duration of study participation
• Has a residence with access to WiFi

Exclusion Criteria:

• Has a pacemaker
• Illicit drug use in the past month
• Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
• Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
• Cohabiting with a current or previous participant in this study
• Evidence of Cognitive Impairment (a score of <18 on the abbreviated Montreal Cognitive Assessment [MoCA] screening evaluation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBTi with Application; Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).	Combination product: CBTi with Application; Participants randomized to this study arm will experience an attempted enhancement of standard video conferencing CBTi, that is facilitated with electronic device-based data and resources to the clinician. Noninvasive ambulatory worn and nearable devices deliver feedback of data to the clinician on an application interface. This information will be used to inform the therapeutic approach and to facilitate a living-space environment that is conducive to effective therapy.; Other Names: Cognitive-Behavioral Therapy for Insomnia - Enhanced
Active Comparator: CBTi; Standard CBTi delivered via video conferencing [Zoom Health].	Behavioral: CBTi; Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.; Other Names: Cognitive-Behavioral Therapy for Insomnia - Standard
Active Comparator: Sleep Hygiene; Treatment as usual: Sleep hygiene education and training.	Behavioral: Sleep Hygiene Education; Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Severity Index	Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.	Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Maintenance Efficiency	Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Sleep Maintenance Efficiency will be calculated (i.e. percentage of time between sleep onset and awakening for the main sleep period that is spent in the sleep state). Minimum score: 0% (i.e. no sleep); Maximum score: 100% (i.e. no awake time during the sleep window). Higher percentage score indicates that a greater proportion of the rest interval was spent actually asleep; increase in percentage score suggests improvement in sleep quality.	Nightly (each night throughout study weeks 1-8)
Change in Total Sleep Time	Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Total Sleep Time will be calculated (i.e. total minutes of nocturnal sleep). An increase in sleep time indicates improvement in sleep quantity.	Nightly (each night throughout study weeks 1-8)
Change in Self-Reported Sleep	Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, etc).	Daily (each morning throughout study weeks 1-8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to clinical therapeutic prescription	Attendance and completion of clinically assigned behavioral tasks (subjective patient self-report and evidence from objective data from ambulatory and nearable IoT devices).	Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week)
Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation	Blood biomarkers suggestive of Alzheimer's disease and related dementias (ADRD), including beta-amyloid (Aβ), Tau, Neurofilament Light chain protein, glial fibrillary acidic protein (GFAP), and brain-derived neurotrophic factor (BDNF). Blood biomarkers indicative of inflammation, including tumor necrosis factor-alpha (TNFα) and Interleukin inflammatory cytokines.	Baseline (week 2) vs. Post-Treatment (8th week)
Change in C-reactive Protein (CRP; mg/L)	C-reactive Protein (CRP), a blood biomarker indicative of inflammation.	Baseline (week 2) vs. Post-Treatment (8th week)
Change in cognitive test battery performance	Objective test performance metrics on an ambulatory cognitive test battery delivered with a smartphone device.	Daily: Baseline (throughout 1st-2nd study weeks) and Post-Treatment (throughout 8th study week)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: University of Arizona; Proactive Life Inc
• Investigators: Principal Investigator: Daniel Taylor, Ph.D., The University of Arizona; Principal Investigator: Daniel Gartenberg, Ph.D., Sleep Space, Inc.; Principal Investigator: Orfeu M Buxton, Ph.D., The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: sleep; insomnia; cognitive-behavioral therapy (CBT); ADRD
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Sleep Initiation and Maintenance Disorders; Alzheimer Disease
• Other Study ID Numbers: R44AG056250 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No