Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

Recruiting

• Conditions: Parkinson Disease
• Interventions: Procedure: Deep brain stimulation

• Registration Number: NCT05348837
• Lead Sponsor: University of Colorado, Denver

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subthalamic nucleus (STN) DBS	Deep brain stimulation	Patients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group.
Globus pallidus interna (GPi) DBS	Deep brain stimulation	Patients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group.

Primary Outcome Measures

Name	Time	Method
Change in total sleep time (TST) as measured by polysomnogram-capable headband	Baseline; 6 months	The total amount of time spent asleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).

Secondary Outcome Measures

Name	Time	Method
Change in sleep efficiency (SE) as measured by polysomnogram-capable headband	Baseline; 6 months	SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Change in sleep efficiency (SE) as measured by actigraphy	Baseline; 6 months	SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by actigraphy.
Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband	Baseline; 6 months	SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Change in sleep onset latency (SOL) as measured by actigraphy	Baseline; 6 months	SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by actigraphy.
Change in wake after sleep onset (WASO) as measured by actigraphy	Baseline; 6 months	WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by actigraphy.
Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband	Baseline; 6 months	WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Change in total sleep time (TST) as measured by actigraphy	Baseline; 6 months	Total amount of time spent asleep, averaged over the 3-night study period, will be measured by actigraphy

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States