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出境医 / 临床实验 / Chronic Insomnia and CSF Markers of Dementia

Chronic Insomnia and CSF Markers of Dementia

Study Description
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

Study Design
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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, 2021
Estimated Study Completion Date : January 30, 2022
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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
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).
Contacts and Locations

Contacts
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Contact: Holly Barilla, MS 215-746-4384 holly.barilla@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Holly Barilla    215-746-4384    holly.barilla@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Philip Gehrman, PhD University of Pennsylvania
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 18, 2019
Last Update Posted Date April 12, 2021
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019) 		CSF markers related to dementia [ Time Frame: one morning ]
CSF levels of the proteins tau and beta amyloid
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2019) 		CSF levels of orexin [ Time Frame: one morning ]
Orexin is a chemical in the brain related to sleep regulation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Insomnia and CSF Markers of Dementia
Official Title Chronic Insomnia and CSF Markers of Dementia
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults with chronic insomnia and matched good sleepers
Condition Insomnia Chronic
Intervention Other: lumbar puncture
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Study Groups/Cohorts
  • Individuals with insomnia
    Men and women with chronic insomnia (>5 years duration)
    Intervention: Other: lumbar puncture
  • Good sleepers
    Men and women with a longstanding pattern of good sleep
    Intervention: Other: lumbar puncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019) 		30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Holly Barilla, MS 215-746-4384 holly.barilla@pennmedicine.upenn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024020
Other Study ID Numbers 829221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Philip Gehrman, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date April 2021

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