Last reviewed · How we verify
NCT04073992
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
NA trial testing cognitive behavioral treatment of insomnia in Insomnia Chronic in 9 participants. Completed in 30 December 2022.
30 November 2022
Quick facts
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 September 2019 |
| Primary completion | 30 November 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- cognitive behavioral treatment of insomnia
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
Sponsor
University of Pennsylvania
Who can join
Adults 30 to 50, any sex, with Insomnia Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years. The purpose of this study is to examine whether treatment of insomnia with cognitive behavioral therapy (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and then repeat CSF sampling.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04073992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia Chronic
Currently open trials in the same condition.
- NCT07387406 — Sleep Learning Education and Empowerment for Older Korean Immigrants · NA · recruiting
- NCT07089797 — Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers · NA · recruiting
- NCT06736548 — Sleep Treatment Education Program for Cancer Survivors: STEP-Together · NA · recruiting
- NCT06926348 — Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample · NA · recruiting
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
Other University of Pennsylvania trials
Trials by the same sponsor.
- NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
- NCT07415772 — Effect of cTBS on Startle and TMS-evoked BOLD · NA · not yet recruiting
- NCT07489430 — DaxibotulinumtoxinA for Blepharospasm · Phase 2 · not yet recruiting
- NCT07463131 — Negative Income Tax Trial · NA · not yet recruiting
- NCT06645769 — Na-Phenylbutyrate VAscular Trial · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04073992 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
- Last refreshed: 17 January 2023
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/NCT04073992.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing