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Chronic Insomnia and CSF Markers of Dementia | Clinical Trials | Clareo Health

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COMPLETEDNCT04024020

Chronic Insomnia and CSF Markers of Dementia

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 evi...

Lead sponsor: University of Pennsylvania•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Pennsylvania

Collaborators

Merck Sharp & Dohme LLC

Age

30 - 50 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age 30-50
•Men and women
•To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance

Exclusion Criteria

•Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
•Women who have been pregnant or lactating within the past six months
•Non-fluency in spoken or written English
•Current or past month shiftwork defined as working during the evening or night shift
•Current use of medications or OTC products that impact sleep
•Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 23, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment30

Start dateJan 2019

Last updatedJan 23, 2025

Condition

Insomnia Chronic

Locations shown

University of Pennsylvania

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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