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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877861
• Other study ID #: NSJT-1701
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2021
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma
• Glioma

Intervention

Device:
• Readiband Sleep Tracking
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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score		Participant enrollment to 12 months (or until tumor progression)