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

• ClinicalTrials.gov Identifier: NCT03877861
• Recruitment Status: Completed
• First Posted: March 18, 2019
• Last Update Posted: June 9, 2021
• Sponsor: Allina Health System
• Information provided by (Responsible Party): Allina Health System

Study Description

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.

Condition or disease	Intervention/treatment
Glioma; Glioblastoma	Device: Readiband Sleep Tracking

Study Design

• Study Type: Observational
• Actual Enrollment: 7 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
• Actual Study Start Date: March 15, 2018
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: May 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Readiband Sleep Tracking - Patient; This group is comprised of 25 participants with a diagnosis of primary Grade IV glioma. A Readiband™ Sleep Tracker device will be provided to each participant, along with necessary instructions. Participantswill return home with the device and fatigue data will be obtained from the device at subsequent standard care follow-up visits.	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.
Readiband Sleep Tracking - Control; Aggregate fatigue data and sleep patterns for a group of 30 healthy controls procured from FatigueScience in a de-identified manner for data analysis purposes.	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.

Outcome Measures

Primary Outcome Measures :

1. Correlation between sleep patterns and disease progression/recurrence [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]
   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.

Secondary Outcome Measures :

1. Correlation between SAFTE fatigue predictions and self-reported fatigue levels [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]
   An estimate of correlation between SAFTE fatigue predictions and self-reported fatigue levels in patients with GBM
2. Sleep pattern differences between healthy controls and brain tumor patients [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]
   Comparison of differences in sleep patterns in brain tumor patients to those of the general population.
3. Correlation between fatigue and sleep patterns and treatment tolerance/success [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]
   An estimate of correlation between fatigue and sleep patterns and treatment tolerance/success, as determined by MRI imaging and RANO criteria.
4. Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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)

Contacts and Locations

Locations

United States, Minnesota

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Sponsors and Collaborators

Allina Health System

Investigators

• Principal Investigator: John Trusheim, MD; Allina Health

More Information

• Responsible Party: Allina Health System
• ClinicalTrials.gov Identifier: NCT03877861
• Other Study ID Numbers: NSJT-1701
• First Posted: March 18, 2019
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Glioblastoma; Glioma; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue