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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045