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

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)