Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03877861 |
Recruitment Status :
Recruiting
First Posted : March 18, 2019
Last Update Posted : May 5, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Glioma Glioblastoma | Device: Readiband Sleep Tracking |
Study Type : | Observational |
Estimated Enrollment : | 25 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 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
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. |
- 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.
- 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
- 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.
- 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.
- Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score [ Time Frame: Participant enrollment to 12 months (or until tumor progression) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877861
Contact: Amy Ellenberger, CCRC | 612/863-6562 | Amy.Ellenberger@allina.com | |
Contact: Emily Shoemaker, MPH | 612-863-0324 | Emily.Shoemaker@allina.com |
United States, Minnesota | |
Abbott Northwestern Hospital | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Contact: Amy Ellenberger 612-863-3452 Amy.Ellenberger@allina.com |
Principal Investigator: | John Trusheim, MD | Allina Health |
Responsible Party: | Allina Health System |
ClinicalTrials.gov Identifier: | NCT03877861 |
Other Study ID Numbers: |
NSJT-1701 |
First Posted: | March 18, 2019 Key Record Dates |
Last Update Posted: | May 5, 2020 |
Last Verified: | May 2020 |
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 |
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |