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



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:22 - 70
Updated:3/21/2019
Start Date:March 15, 2018
End Date:December 31, 2020
Contact:Amy Ellenberger, CCRC
Email:Amy.Ellenberger@allina.com
Phone:612/863-6562

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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

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.


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:

1. Thrombocytopenia (platelet count < 100 x 103/μL)

2. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)

3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)

4. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal

5. Total bilirubin > upper limit of normal, if clinically significant

6. Significant renal impairment (serum creatinine > 1.7 mg/dL)
We found this trial at
1
site
800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Phone: 612-863-3452
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Minneapolis, MN
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