RecruitingNCT05348837

Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease


Sponsor

University of Colorado, Denver

Enrollment

15 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether wearable devices (a wristband and a headband) can accurately measure sleep patterns in people with Parkinson's disease in their own home, over a 2-week period. It also explores how temporarily pausing certain Parkinson's medications in the evening affects sleep. **You may be eligible if...** - You have Parkinson's disease - You are willing and able to wear a wristband and headband sleep monitor for two weeks - You can keep a daily log of your sleep, eating, and medication schedule - You are willing to withhold your Parkinson's medications after 5pm for three consecutive nights **You may NOT be eligible if...** - You have been diagnosed with dementia (such as Parkinson's disease dementia or dementia with Lewy bodies) - You have used sleep medications (like Zolpidem or Eszopiclone) in the past 30 days - You have a diagnosed circadian rhythm sleep disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDeep brain stimulation

Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT05348837


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