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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
Sponsor:
Information provided by (Responsible Party):
Allina Health System

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Groups and Cohorts
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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
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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
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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
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Information from the National Library of Medicine

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


Contacts
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Contact: Amy Ellenberger, CCRC 612/863-6562 Amy.Ellenberger@allina.com
Contact: Emily Shoemaker, MPH 612-863-0324 Emily.Shoemaker@allina.com

Locations
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United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Amy Ellenberger    612-863-3452    Amy.Ellenberger@allina.com   
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: John Trusheim, MD Allina Health
More Information
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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

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