Chronic Insomnia and CSF Markers of Dementia

Completed

• Conditions: Insomnia Chronic
• Interventions: Other: lumbar puncture

• Registration Number: NCT04024020
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-18
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with insomnia	lumbar puncture	Men and women with chronic insomnia (\>5 years duration)
Good sleepers	lumbar puncture	Men and women with a longstanding pattern of good sleep

Primary Outcome Measures

Name	Time	Method
CSF markers related to dementia	one morning	CSF levels of the proteins tau and beta amyloid

Secondary Outcome Measures

Name	Time	Method
CSF levels of orexin	one morning	Orexin is a chemical in the brain related to sleep regulation

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States