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Chronic Insomnia and CSF Markers of Dementia

University of Pennsylvania logo

University of Pennsylvania

Status

Completed

Conditions

Insomnia Chronic

Treatments

Other: lumbar puncture

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

30 to 50 years old

Volunteers

No 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).

Trial design

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Holly Barilla, MS

Data sourced from clinicaltrials.gov

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