CompletedPhase 2/3

Enhanced CBTi for Older Adult Sleep and Cognition

United States60 participantsStarted 2022-03-16

Plain-language 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).

Who can participate

Age range

60 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insomnia Severity Index

Timeframe: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)

Trial details

NCT IDNCT05015803

SponsorPenn State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-14

View on ClinicalTrials.gov More Insomnia trials

Who can participate

Age range

60 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.