Clinical trial NCT03877861: Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
Official title: Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Glioblastoma
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 7
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Grade IV gliomas treated at Abbott Northwestern Hospital's Givens Brain Tumor Center will comprise the study population. Patients enrolled in this study must intend to complete post-surgery chemoradiation as part of their standard treatment. Twenty-five patients will prospectively be included in the study. Aggregate fatigue data and sleep patterns for a group of 30 healthy controls will be procured from FatigueScience in a de-identified manner for data analysis purposes.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Correlation between sleep patterns and disease progression/recurrence
timeFrame: Participant enrollment to 12 months (or until tumor progression)
Secondary outcomes:
measure: Correlation between SAFTE fatigue predictions and self-reported fatigue levels
timeFrame: Participant enrollment to 12 months (or until tumor progression)
measure: Sleep pattern differences between healthy controls and brain tumor patients
timeFrame: Participant enrollment to 12 months (or until tumor progression)
measure: Correlation between fatigue and sleep patterns and treatment tolerance/success
timeFrame: Participant enrollment to 12 months (or until tumor progression)
measure: Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score
timeFrame: Participant enrollment to 12 months (or until tumor progression)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: John Trusheim, MD
role: PRINCIPAL_INVESTIGATOR
References: