Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT05015803
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT05015803
Study Brief:
Protocol Section:
NCT05015803