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

You may not qualify if:

• 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)