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

Study Overview
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Brief Summary
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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.

Official Title
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Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma

Conditions
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Glioma, Glioblastoma

Intervention / Treatment
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* Device: Readiband Sleep Tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria i. Patients aged between 22 and 70. ii. Patients must have a histologic diagnosis of primary Grade IV glioma. iii. Patients must have received maximal debulking surgery and radiotherapy concomitant with Temozolomide (≥ 75% of their recommended temozolomide dosage is required). iv. Patients with KPS ≥70. v. Life expectancy at least 3 months. vi. Patients must have signed informed consent for study participation. vii. Patients should be English speakers. Exclusion Criteria i. Patients enrolled in active clinical treatment trials for primary Grade IV glioma. ii. Patients with progressive disease after completion of radiotherapy concomitant with Temozolomide as per RANO criteria. Suspected pseudoprogression should be confirmed by additional imaging studies ordered as part of standard care. iii. Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies). iv. Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration. vi. Patients with infra-tentorial tumors. vii. Patients with known psychiatric concerns. viii. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment: Thrombocytopenia (platelet count < 100 x 103/μL) Neutropenia (absolute neutrophil count < 1.5 x 103/μL) CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) Significant liver function impairment - AST or ALT > 3 times the upper limit of normal Total bilirubin > upper limit of normal, if clinically significant Significant renal impairment (serum creatinine > 1.7 mg/dL)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Readiband Sleep Tracking - Patient<br>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. | Device: Readiband Sleep Tracking<br>* 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.<br>|
| Readiband Sleep Tracking - Control<br>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. | Device: Readiband Sleep Tracking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between sleep patterns and disease progression/recurrence | 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. | Participant enrollment to 12 months (or until tumor progression) | 

Secondary Outcome Measures

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