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Chronic Insomnia and CSF Markers of Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04024020
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Insomnia Chronic Other: lumbar puncture

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Chronic Insomnia and CSF Markers of Dementia
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort Intervention/treatment
Individuals with insomnia
Men and women with chronic insomnia (>5 years duration)
Other: lumbar puncture
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Good sleepers
Men and women with a longstanding pattern of good sleep
Other: lumbar puncture
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection

Primary Outcome Measures :
  1. CSF markers related to dementia [ Time Frame: one morning ]
    CSF levels of the proteins tau and beta amyloid

Secondary Outcome Measures :
  1. CSF levels of orexin [ Time Frame: one morning ]
    Orexin is a chemical in the brain related to sleep regulation

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adults with chronic insomnia and matched good sleepers

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04024020

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Contact: Holly Barilla, MS 215-746-4384

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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Holly Barilla    215-746-4384   
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.

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Responsible Party: University of Pennsylvania Identifier: NCT04024020     History of Changes
Other Study ID Numbers: 829221
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders