Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05348837

Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

Led by University of Colorado, Denver · Updated on 2025-04-04

15

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 and impact of non-motor symptoms become the focus of intense study. Disturbances of sleep are among the most common non-motor manifestations of PD; approximately two-thirds of PD patients experience sleep dysfunction of some kind. Given that sleep contributes to the regulation of many physiological processes, sleep disturbance has a significant impact on quality of life in PD, and places high strain on caregivers. Though numerous symptomatic therapies exist, the treatment of sleep disorders in PD is limited by a lack of adequately powered, randomized studies providing high quality evidence. Although deep brain stimulation (DBS) is primarily used to treat PD motor symptoms and reduce the need for dopaminergic medications, several studies have shown that DBS provides benefit for non-motor symptoms, including sleep disturbance. Few studies have used an objective measure to assess the impact of DBS on sleep in PD, and none have done so by studying sleep in the home environment. Existing studies have largely been limited to a single night of sleep recording in a sleep lab. Furthermore, no studies have assessed sleep both on and off medication, before and after DBS implantation. This study will enroll patients undergoing evaluation for DBS implantation. Sleep will be assessed before DBS implantation, both while patients continue their usual medication regimen and while withholding medications. After DBS implantation and programming, sleep will again be assessed with stimulation on, both while continuing medications and subsequently while withholding medications.

CONDITIONS

Official Title

Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to learn to use and maintain a wristband-style sleep monitor
  • Able to wear a wristband-style sleep monitor for two weeks
  • Willing and able to learn to use and maintain a headband sleep monitor
  • Able to wear a headband sleep monitor for two weeks
  • Able to log daily routine events including sleeping, eating, and medication regimens for two weeks
  • Able to withhold dopaminergic medications after 5:00pm for three consecutive nights
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia such as Parkinson's Disease Dementia or Dementia with Lewy Bodies
  • Current or recent (within 30 days) use of sedative-hypnotic sleep medications (e.g., Zolpidem, Suvorexant, Eszopiclone)
  • Diagnosis or criteria for circadian sleep-wake rhythm disorder as defined by the International Classification of Sleep Disorders, Third Edition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

L

Lisa Hirt

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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