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Behavioural Intervention

CBTi with Application for Insomnia (R44 Trial)

Phase 2 & 3

Waitlist Available

Led By Daniel Gartenberg, Ph.D.

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week)

Awards & highlights

R44 Trial Summary

This trial will attempt to improve sleep and health outcomes for aged, independent individuals with insomnia using Cognitive Behavioral Therapy for Insomnia (CBTi).

Eligible Conditions

Insomnia
Alzheimer's Disease

R44 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily: during intervention (throughout 3rd-7th study weeks) and post-treatment (throughout 8th study week) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Insomnia Severity Index

Secondary outcome measures

Change in Self-Reported Sleep

Change in Sleep Maintenance Efficiency

Change in Total Sleep Time

Other outcome measures

Adherence to clinical therapeutic prescription

Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation

Change in C-reactive Protein (CRP; mg/L)

+1 more

R44 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: CBTi with ApplicationExperimental Treatment1 Intervention

Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi).

Group II: Sleep HygieneActive Control1 Intervention

Treatment as usual: Sleep hygiene education and training.

Group III: CBTiActive Control1 Intervention

Standard CBTi delivered via video conferencing [Zoom Health].

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBTi with Application

2022

Completed Phase 3

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER

514 Previous Clinical Trials

148,211 Total Patients Enrolled

4 Trials studying Insomnia

168 Patients Enrolled for Insomnia

Penn State UniversityLead Sponsor

355 Previous Clinical Trials

125,697 Total Patients Enrolled

1 Trials studying Insomnia

10 Patients Enrolled for Insomnia

Proactive Life IncIndustry Sponsor

Media Library

CBTi (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05015803 — Phase 2 & 3

Insomnia Research Study Groups: Sleep Hygiene, CBTi, CBTi with Application

Insomnia Clinical Trial 2023: CBTi Highlights & Side Effects. Trial Name: NCT05015803 — Phase 2 & 3

CBTi (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05015803 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this research project be investigating individuals over the age of 35?

"According to the inclusion criteria for this particular research, individuals must be between 60 and 90 years old."

Answered by AI

Are investigators actively looking for participants at this time?

"This particular clinical trial, as indicated by the website clinicaltrials.gov, is still recruiting patients. The initial posting was on December 14th 2021 and there was a most recent update on July 13th 2022."

Answered by AI

How can I sign up to participate in this research?

"This trial is admitting 130 people with Alzheimer's disease aged 60 and 90. Most importantly, applicants are required to meet the following 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, Will"

Answered by AI

How many people are currently signed up for this clinical trial?

"Yes, you're right. The clinical trial is currently ongoing and looking for 130 patients at 1 location, according to the latest update on July 13th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhanced CBTi for Older Adult Sleep and Cognition

Orfeu M. Buxton 2022. "Enhanced CBTi for Older Adult Sleep and Cognition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05015803.