Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms

Completed

• Conditions: Glioblastoma; Glioma
• Interventions: Device: Readiband Sleep Tracking

• Registration Number: NCT03877861
• Lead Sponsor: Allina Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study Start: 2018-03-15
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Readiband Sleep Tracking - Patient	Readiband Sleep Tracking	This group is comprised of 25 participants with a diagnosis of primary Grade IV glioma. A Readiband™ Sleep Tracker device will be provided to each participant, along with necessary instructions. Participantswill return home with the device and fatigue data will be obtained from the device at subsequent standard care follow-up visits.
Readiband Sleep Tracking - Control	Readiband Sleep Tracking	Aggregate fatigue data and sleep patterns for a group of 30 healthy controls procured from FatigueScience in a de-identified manner for data analysis purposes.

Primary Outcome Measures

Name	Time	Method
Correlation between sleep patterns and disease progression/recurrence	Participant enrollment to 12 months (or until tumor progression)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between SAFTE fatigue predictions and self-reported fatigue levels	Participant enrollment to 12 months (or until tumor progression)	An estimate of correlation between SAFTE fatigue predictions and self-reported fatigue levels in patients with GBM
Sleep pattern differences between healthy controls and brain tumor patients	Participant enrollment to 12 months (or until tumor progression)	Comparison of differences in sleep patterns in brain tumor patients to those of the general population.
Correlation between fatigue and sleep patterns and treatment tolerance/success	Participant enrollment to 12 months (or until tumor progression)	An estimate of correlation between fatigue and sleep patterns and treatment tolerance/success, as determined by MRI imaging and RANO criteria.
Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score	Participant enrollment to 12 months (or until tumor progression)

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States