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NCT05348837 · ClinicalTrials.gov registry record
Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
A clinical trial of Parkinson Disease, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- 15
- Enrollment target
- 1
- Study location
NCT05348837: Recruiting study of Parkinson Disease, sponsored by University of Colorado, Denver.
NCT05348837 is a study of Parkinson Disease that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 15 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05348837, a study of Parkinson Disease, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- PROCEDURE Deep brain stimulation
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2025-12-01 |
What NCT05348837 shows while recruiting
NCT05348837 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 1 intervention - of which Deep brain stimulation is the first listed.
NCT05348837 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05348837 about?
NCT05348837 is a clinical study titled "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 ...
What is the current status of trial NCT05348837?
This trial is currently recruiting. The enrollment target is 15 participants. The study started on 2022-05-01. Estimated completion is 2025-12-01.
What conditions does trial NCT05348837 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT05348837?
The interventions under investigation include: Deep brain stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT05348837?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05348837 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05348837's enrollment target sits among peer trials
15 260th of 297 higher than 34 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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