Monitoring sleep patterns in people with Parkinson's disease using wearable devices
Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
This study is testing how sleep patterns are affected in people with Parkinson's disease by using wearable devices to track their sleep over two weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05348837 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess sleep disturbances in individuals with Parkinson's disease by utilizing wristband and headband sleep monitors over a two-week period. Participants will log their daily routines, including sleep, eating, and medication schedules, while refraining from dopaminergic medications after 5:00 PM for three nights. The study seeks to gather high-quality evidence on the prevalence and impact of sleep dysfunction in Parkinson's patients, which is often overlooked despite its significant effect on quality of life. The findings may help inform future treatment strategies for managing sleep disorders in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease who can use and maintain wearable sleep monitors.
Not a fit: Patients with dementia or those currently using sedative-hypnotic agents for sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sleep disorders in Parkinson's disease, enhancing patients' quality of life.
How similar studies have performed: While there is limited high-quality evidence on sleep disorders in Parkinson's disease, previous studies have indicated potential benefits of deep brain stimulation for non-motor symptoms, suggesting a promising area of exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Baumgartner, MD — University of Colorado, Denver
- Study coordinator: Lisa Hirt
- Email: lisa.hirt@cuanschutz.edu
- Phone: 720-848-2080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.