Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep brain stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in total sleep time (TST) as measured by polysomnogram-capable headband [Time frame: Baseline; 6 months]
Secondary outcome measures (7)
- Change in sleep efficiency (SE) as measured by polysomnogram-capable headband [Time frame: Baseline; 6 months]
- Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband [Time frame: Baseline; 6 months]
- Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband [Time frame: Baseline; 6 months]
- Change in total sleep time (TST) as measured by actigraphy [Time frame: Baseline; 6 months]
- Change in sleep efficiency (SE) as measured by actigraphy [Time frame: Baseline; 6 months]
- Change in sleep onset latency (SOL) as measured by actigraphy [Time frame: Baseline; 6 months]
- Change in wake after sleep onset (WASO) as measured by actigraphy [Time frame: Baseline; 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT05348837 · 22-0393