Insomnia Chronic
Conditions
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.
Interventions
OTHERlumbar puncture
Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
Sponsors
Merck Sharp & Dohme LLC
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF Markers Related to Dementia | one morning | CSF levels of the proteins Abeta40 and Abeta42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSF Levels of Orexin | one morning | Orexin is a chemical in the brain related to sleep regulation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Individuals With Insomnia | Good Sleepers | Total |
|---|---|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 9.1 | 43.2 years STANDARD_DEVIATION 9.2 | 43.1 years STANDARD_DEVIATION 9.2 |
| Insomnia Severity Index | 16.5 units on a scale STANDARD_DEVIATION 4.3 | 3.6 units on a scale STANDARD_DEVIATION 3.7 | 10.1 units on a scale STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 8 Participants | 20 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
CSF Markers Related to Dementia
CSF levels of the proteins Abeta40 and Abeta42
Time frame: one morning
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individuals With Insomnia | CSF Markers Related to Dementia | Abeta40 | 4332.1 picograms per milliliter | Standard Deviation 1250.5 |
| Individuals With Insomnia | CSF Markers Related to Dementia | Abeta42 | 393.2 picograms per milliliter | Standard Deviation 122.8 |
| Good Sleepers | CSF Markers Related to Dementia | Abeta40 | 4824.0 picograms per milliliter | Standard Deviation 2336 |
| Good Sleepers | CSF Markers Related to Dementia | Abeta42 | 419.4 picograms per milliliter | Standard Deviation 201.8 |
Secondary
CSF Levels of Orexin
Orexin is a chemical in the brain related to sleep regulation
Time frame: one morning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals With Insomnia | CSF Levels of Orexin | 215.5 picograms per milliliter | Standard Deviation 11.9 |
| Good Sleepers | CSF Levels of Orexin | 214.5 picograms per milliliter | Standard Deviation 28.2 |