NCT05015803 (R44) is a Phase 2, PHASE3 clinical trial of CBTi with Application in Insomnia, sponsored by Penn State University.

Who is sponsoring NCT05015803?

NCT05015803 is sponsored by Penn State University.

What drugs are being tested in NCT05015803?

Interventions in NCT05015803: CBTi with Application, CBTi, Sleep Hygiene Education.

What condition does NCT05015803 study?

NCT05015803 studies Insomnia, Alzheimers Disease Related Dementias.

Is NCT05015803 still recruiting?

NCT05015803 is currently completed. Last updated 12 April 2024.

Last reviewed 2024-04-12 · How we verify

NCT05015803: R44

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Enhanced CBTi for Older Adult Sleep and Cognition

Completed Phase 2, PHASE3 Last updated 12 April 2024

What this trial tests

Phase 2, PHASE3 trial testing CBTi with Application in Insomnia in 60 participants. Completed in 16 August 2023.

Timeline

16 March 2022

Primary endpoint
14 June 2023

16 August 2023

Quick facts

Lead sponsor	Penn State University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	16 March 2022
Primary completion	14 June 2023
Estimated completion	16 August 2023
Sites	1 location across United States

Drugs / interventions tested

CBTi with Application
CBTi
Sleep Hygiene Education

Conditions studied

Insomnia — all drugs for Insomnia →
Alzheimers Disease Related Dementias — all drugs for Alzheimers Disease Related Dementias →

Sponsor

Penn State University

Who can join

Adults 60 to 90, any sex, with Insomnia or Alzheimers Disease Related Dementias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk: Design and methodology of a randomized clinical trial.
Emert SE, Taylor DJ, Gartenberg D, Schade MM, et al · · 2023 · cited 4× · PMID 37380020 · DOI 10.1016/j.cct.2023.107275
NeuroMusic: protocol for a randomised-controlled trial of keyboard and singing music training programmes for older adults with mild cognitive impairment.
Menczel Schrire Z, Mitchell HF, Low LF, Espinosa N, et al · · 2025 · PMID 41360445 · DOI 10.1136/bmjopen-2025-104158

Verify or expand the search:

Other recruiting trials for Insomnia

Currently open trials in the same condition.

NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting

Other Penn State University trials

Trials by the same sponsor.

NCT07147387 — Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk · NA · not yet recruiting
NCT07266506 — Development of an Eating Behavior Risk Score · NA · not yet recruiting
NCT07229781 — Mediterranean Diet and Blood Sugar Study · NA · not yet recruiting
NCT07235358 — Cardiometabolic Effects of Pecan Snacking in Prediabetes · NA · not yet recruiting
NCT06823518 — Thrive Initiative Parent-Education Programming Study · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05015803 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Penn State University
Last refreshed: 12 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05015803.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing