Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Deep brain stimulation

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Lisa Hirt; Phone Number: 720-848-2080; Email: lisa.hirt@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Pamela Gerecht, PhD; Phone Number: 303-724-4134; Email: pamela.davidgerecht@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing evaluation for DBS candidacy are eligible to participate in this study. Those deemed appropriate for DBS implantation and who undergo bilateral DBS will complete the second (post-operative) phase of the study. Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. Decision to participate in the study will have no bearing on DBS candidacy. Patients are eligible to participate in this study regardless of device being implanted.

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subthalamic nucleus (STN) DBS; Patients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group.	Procedure: Deep 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.
Globus pallidus interna (GPi) DBS; Patients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group.	Procedure: Deep 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total sleep time (TST) as measured by polysomnogram-capable headband	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).	Baseline; 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep efficiency (SE) as measured by polysomnogram-capable headband	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).	Baseline; 6 months
Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband	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).	Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband	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).	Baseline; 6 months
Change in total sleep time (TST) as measured by actigraphy	Total amount of time spent asleep, averaged over the 3-night study period, will be measured by actigraphy	Baseline; 6 months
Change in sleep efficiency (SE) as measured by actigraphy	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.	Baseline; 6 months
Change in sleep onset latency (SOL) as measured by actigraphy	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.	Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by actigraphy	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.	Baseline; 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI) score	The PSQI is a well-validated clinical questionnaire that queries subjects on seven sleep parameters.	Baseline; 6 months
Change in Parkinson Disease Sleep Scale, version 2 (PDSS-2) score	The PDSS-2 is a 15-item scale which specifically queries several sleep disturbances commonly afflicting PD patients, including restless leg syndrome, nocturia, pain, and sleep apnea	Baseline; 6 months
Change in Fatigue Severity Scale (FSS) score	The FSS is a nine-item scale that measures the severity of fatigue and its impact on daily life.	Baseline; 6 months
Change in Epworth Sleepiness Scale (ESS) score	The ESS is a self-administered, eight-item assessment of daytime sleepiness.	Baseline; 6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Alexander Baumgartner, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 22-0393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No