N/A
Completed N=30
Chronic Insomnia and CSF Markers of Dementia
Insomnia Chronic
Source: ClinicalTrials.gov NCT04024020 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: CSF Markers Related to Dementia — 4332.1; 4824.0; 393.2; 419.4 picograms per milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSF Markers Related to Dementia |
4332.1; 4824.0; 393.2; 419.4 | — |
| SECONDARY CSF Levels of Orexin |
215.5; 214.5 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04024020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.