Status:
RECRUITING
Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
Lead Sponsor:
University of Colorado, Denver
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Brief Summary
The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence ...
Eligibility Criteria
Inclusion
- Research subjects must be willing and able to do the following:
- Be able to learn to use and maintain a wristband-style sleep monitor
- Wear a wristband-style sleep monitor for two weeks
- Be able to learn to use and maintain a headband sleep monitor
- Wear a headband sleep monitor for two weeks
- Log daily routine events, such sleeping, eating, and medication regimens for the two-week study period
- Withhold dopaminergic medications after 5:00pm for three consecutive nights
Exclusion
- Subjects will be excluded if they:
- Carry a diagnosis of dementia (e.g., Parkinson's Disease Dementia or Dementia with Lewy Bodies)
- Currently use or recently (within past 30 days) used a sedative-hypnotic agent for sleep (e.g., Zolpidem, Suvorexant, Eszopiclone)
- Fulfill criteria or carry a diagnosis of a circadian sleep-wake rhythm disorder, as defined by the International Classification of Sleep Disorders, Third Edition
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05348837
Start Date
May 1 2022
End Date
December 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045