Enhanced CBTi for Older Adult Sleep and Cognition (R44)

• ClinicalTrials.gov Identifier: NCT05015803
• Recruitment Status: Completed
• First Posted: August 20, 2021
• Last Update Posted: April 12, 2024
• Sponsor: Penn State University
• Collaborators: University of Arizona; Proactive Life Inc
• Information provided by (Responsible Party): Orfeu M. Buxton, Penn State University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Insomnia; Alzheimers Disease Related Dementias	Combination Product: CBTi with Application; Behavioral: CBTi; Behavioral: Sleep Hygiene Education	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.
• Masking: Single (Participant)
• Masking Description: This is a single-blind study design. The therapeutic care for insomnia is synonymous with the study intervention, therefore blinding of the CBT care provider is impossible.
• Primary Purpose: Treatment
• Official Title: A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk
• Actual Study Start Date: March 16, 2022
• Actual Primary Completion Date: June 14, 2023
• Actual Study Completion Date: August 16, 2023

Arms and Interventions

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 Name: 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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Insomnia Severity Index [ Time Frame: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8) ]
   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.

Secondary Outcome Measures :

1. Change in Sleep Maintenance Efficiency [ Time Frame: Nightly (each night throughout study weeks 1-8) ]
   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.
2. Change in Total Sleep Time [ Time Frame: Nightly (each night throughout study weeks 1-8) ]
   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.
3. Change in Self-Reported Sleep [ Time Frame: Daily (each morning throughout study weeks 1-8) ]
   Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, etc).

Other Outcome Measures:

1. Change in cognitive test battery performance [ Time Frame: Daily: Baseline (throughout 1st-2nd study weeks) and Post-Treatment (throughout 8th study week) ]
   Objective test performance metrics on an ambulatory cognitive test battery delivered with a smartphone device.
2. Adherence to clinical therapeutic prescription [ Time Frame: Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week) ]
   Attendance and completion of clinically assigned behavioral tasks (subjective patient self-report and evidence from objective data from ambulatory and nearable IoT devices).
3. Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation [ Time Frame: Baseline (week 2) vs. Post-Treatment (8th week) ]
   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.
4. Change in C-reactive Protein (CRP; mg/L) [ Time Frame: Baseline (week 2) vs. Post-Treatment (8th week) ]
   C-reactive Protein (CRP), a blood biomarker indicative of inflammation.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Pennsylvania

The Pennsylvania State University

University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

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

More Information

• Responsible Party: Orfeu M. Buxton, Elizabeth Fenton Susman Professor of Biobehavioral Health, Penn State University
• ClinicalTrials.gov Identifier: NCT05015803
• Other Study ID Numbers: R44AG056250 ( U.S. NIH Grant/Contract )
• First Posted: August 20, 2021
• Last Update Posted: April 12, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Orfeu M. Buxton, Penn State University:

cognitive-behavioral therapy (CBT); sleep; ADRD; insomnia

Additional relevant MeSH terms:

Alzheimer Disease; Sleep Initiation and Maintenance Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders