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NCT03877861 · ClinicalTrials.gov registry record
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
A clinical trial, sponsored by Allina Health System.
- Completed
- Registry status
- 7
- Enrollment target
NCT03877861: Completed study, sponsored by Allina Health System.
NCT03877861 is a clinical trial that has completed, run by Allina Health System. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03877861 has completed, sponsored by Allina Health System.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. The SAFTE model will be used to asses cancer-related fatigue and study potential associations of change in sleep patterns to tumor recurrence in patients with high grade glioma. Data will be collected using the Readiband™ Sleep Tracker (https://www.fatiguescience.com/sleep-science-technology/). The Readiband device captures high-resolution sleep data, validated against the clinical gold standard of polysomnography with 92% accuracy. Sleep data is transmitted to the cloud automatically for SAFTE Fatigue Model analysis. We will correlate clinical progression data obtained from the patient's electronic medical record with SAFTE data.
Primary Outcome
An estimate of correlation between sleep patterns in the brain tumor patient population and disease progression or recurrence compared to those of the general population.
Interventions
- DEVICE Readiband Sleep Tracking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2021-05-01 |
What the finished NCT03877861 record still lists
NCT03877861 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Readiband Sleep Tracking is the first listed.
NCT03877861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03877861 about?
NCT03877861 is a clinical study titled "Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms". This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. The SAFTE model will be used to asses cancer-...
What is the current status of trial NCT03877861?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2018-03-15. Estimated completion is 2021-05-01.
What interventions are being tested in trial NCT03877861?
The interventions under investigation include: Readiband Sleep Tracking (DEVICE).
Who is sponsoring clinical trial NCT03877861?
This trial is sponsored by Allina Health System, which has 32 total clinical trials registered on ClinicalTrials.gov.
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