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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with insomnia | Men and women with chronic insomnia (>5 years duration) |
| |
| Good sleepers | Men and women with a longstanding pattern of good sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar puncture | Other | Subjects will have a lumbar puncture to collect cerebrospinal fluid collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| CSF Markers Related to Dementia | CSF levels of the proteins Abeta40 and Abeta42 | one morning |
| Measure | Description | Time Frame |
|---|---|---|
| CSF Levels of Orexin | Orexin is a chemical in the brain related to sleep regulation | one morning |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with chronic insomnia and matched good sleepers
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| Name | Affiliation | Role |
|---|---|---|
| Philip Gehrman, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals With Insomnia | Men and women with chronic insomnia (>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection |
| FG001 | Good Sleepers | Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individuals With Insomnia | Men and women with chronic insomnia (>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection |
| BG001 | Good Sleepers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CSF Markers Related to Dementia | CSF levels of the proteins Abeta40 and Abeta42 | Posted | Mean | Standard Deviation | picograms per milliliter | one morning |
|
up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individuals With Insomnia | Men and women with chronic insomnia (>5 years duration) lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
The participants in this study had relatively mild insomnia, so it is not known whether the same pattern would be found for more severe cases. The size of this study is also relatively small so larger studies are needed to have more conclusive results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip Gehrman | University of Pennsylvania | 2157463578 | philip.gehrman@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Dec 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Men and women with a longstanding pattern of good sleep
lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insomnia Severity Index | This scale provides a measure of overall severity of insomnia, with higher scores indicating more severe symptoms. Scores range from 0 to 28. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | CSF Levels of Orexin | Orexin is a chemical in the brain related to sleep regulation | Posted | Mean | Standard Deviation | picograms per milliliter | one morning |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Good Sleepers | Men and women with a longstanding pattern of good sleep lumbar puncture: Subjects will have a lumbar puncture to collect cerebrospinal fluid collection | 0 | 15 | 0 | 15 | 1 | 15 |
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| D001523 |
| Mental Disorders |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |