Chronic insomnia and CSF markers of dementia

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Study Overview

The purpose of this study is to identify the relationship between chronic sleep disturbance and proteins in spinal fluid that are related to dementia and a molecule called orexin that helps regulate wakefulness and appetite in the brain. Individuals with sleep problems and good sleepers will be asked to participate.

Study Description

If you agree to participate your participation would involve two visits. Both visits would take place at the Center for Human Phenomic Science (CHPS; formerly the Clinical and Translational Research Center) at the Hospital of the University of Pennsylvania.

For the first visit, you would answer some questions about your sleep, thoughts and feelings. You would be asked to wear an activity monitoring device called an actiwatch for one week at home and complete a sleep diary throughout the week. You would also be asked to wear a portable sleep monitor device for one night.
For your second visit you would come to the CHPS at 5:00 pm and be checked into the hospital. During the rest of the evening you would be free to engage in activities of your own choosing including watching TV, reading, or talking on your personal phone. During the night you are in the CHPS, your sleep would be monitored. 
 
At 8 am, a neurologist experienced with this procedure would conduct a neurological exam prior to performing a lumbar puncture to collect your cerebrospinal fluid (“CSF”). The exam would be used to be sure you do not have any medical conditions that would make the lumbar puncture unsafe to perform.

The lumbar puncture is generally considered a safe procedure, and involves placing a thin needle below where the spinal cord is so there’s no risk of damage. Lidocaine is used to numb the area so most patients experience some pressure during the procedure but no pain. A small number of patients experience a temporary headache afterwards.

 

Additional Information:

You would be compensated $25 for completion of the screening visit and $300 for the 22 hours spent in the hospital, for a total of $325 if you complete the entire study.

Subjects with insomnia will have the option of participating in phase 2, where they would receive Cognitive-Behavioral Therapy for Insomnia (CBT-I) for 6-8 weeks and then repeat the hospital visit for a second lumbar puncture:
https://clinicalresearch.itmat.upenn.edu/clinicaltrial/6245/tbd-chronic-insomnia-csf-markers/?qd=1939827

  • Study Identifier: 829221

Recruitment Status

Open

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