Status:
COMPLETED
Chronic Insomnia and CSF Markers of Dementia
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Insomnia Chronic
Eligibility:
All Genders
30-50 years
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 evi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04024020
Start Date
January 1 2019
End Date
October 31 2023
Last Update
January 23 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104