A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Insomnia Severity Index
Study Overview
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).
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
CBTi with Application
Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).
Intervention: CBTi with Application (Combination Product)
CBTi
Standard CBTi delivered via video conferencing [Zoom Health].
Intervention: CBTi (Behavioral)
Sleep Hygiene
Treatment as usual: Sleep hygiene education and training.
Intervention: Sleep Hygiene Education (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Change in Sleep Maintenance Efficiency(Nightly (each night throughout study weeks 1-8))
- Change in Total Sleep Time(Nightly (each night throughout study weeks 1-8))
- Change in Self-Reported Sleep(Daily (each morning throughout study weeks 1-8))
Investigators
Orfeu M. Buxton
Elizabeth Fenton Susman Professor of Biobehavioral Health
Penn State University