Enhanced CBTi for Older Adult Sleep and Cognition

Insomnia Clinical Trial

— R44  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015803
• Other study ID #: R44AG056250
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 16, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: April 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 16, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

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.
• Sleep Hygiene Education
Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	Proactive Life Inc, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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 (Aß), 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 (TNFa) and Interleukin inflammatory cytokines.	Baseline (week 2) vs. Post-Treatment (8th week)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)