Trials / Completed
CompletedNCT03877861
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7 (actual)
- Sponsor
- Allina Health System · Academic / Other
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Readiband Sleep Tracking | Once a patient has consented to study progression, a Readiband™ Sleep Tracker device will be provided to the patient, along with necessary instructions. Patients will return home with the device and fatigue data will be obtained from the device at subsequent standard care follow-up visits. In addition, surveys related to fatigue and quality of life will be administered via secure electronic survey to participants. |
Timeline
- Start date
- 2018-03-15
- Primary completion
- 2021-05-01
- Completion
- 2021-05-01
- First posted
- 2019-03-18
- Last updated
- 2021-06-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03877861. Inclusion in this directory is not an endorsement.