Chronic Insomnia and CSF Markers of Dementia

NCT04024020•University of Pennsylvania

Summary

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 the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.

Eligibility

Age

30 - 50 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 1, 2019

Primary Completion Date

October 31, 2023

Completion Date

October 31, 2023

Last Updated

January 23, 2025

Enrollment

ACTUAL participants

Conditions

Insomnia Chronic

Interventions

lumbar puncture

OTHER

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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: March 29, 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.

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Chronic Insomnia and CSF Markers of Dementia

Inclusion Criteria

Exclusion Criteria

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