Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2022-03-16
2023-08-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)
NCT05226585
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers
NCT03538574
Assessing Modified CBTi in Adults with Insomnia Disorder
NCT06600516
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
NCT01550172
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
NCT00133601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBTi with Application
Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).
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.
CBTi
Standard CBTi delivered via video conferencing \[Zoom Health\].
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
Treatment as usual: Sleep hygiene education and training.
Sleep Hygiene Education
Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
60 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Arizona
OTHER
Proactive Life Inc
INDUSTRY
Penn State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Orfeu M. Buxton
Elizabeth Fenton Susman Professor of Biobehavioral Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Taylor, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Arizona
Daniel Gartenberg, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sleep Space, Inc.
Orfeu M Buxton, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Pennsylvania State University
University Park, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.