Who is eligible for clinical trial NCT05348837?

Participants must meet the protocol's inclusion criteria for Parkinson Disease. The stated age range is 18 Years to 80 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05348837 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-04-02

Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease (NCT05348837)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University of Colorado, Denver

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (4 items).

Location: University of Colorado Anschutz Medical Campus — Aurora, Colorado

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

Deep brain stimulation (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Colorado Anschutz Medical Campus — Aurora, Colorado

📞 Contact the Study Coordinator

Phone: (720) 848-2080

Email: lisa.hirt@cuanschutz.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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The GBA Multimodal Study in Parkinson's Disease — Portland, Oregon
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Explore by condition: All Parkinson Disease clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗