GliomaNCT03877861
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
An observational study of Glioma and Glioblastoma, run by Allina Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Glioma, Glioblastoma
- What is being tested?
- Readiband Sleep Tracking
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- 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.
Who cannot join
- Patients enrolled in active clinical treatment trials for primary Grade IV glioma.
- 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.
- Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies).
- Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration.
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
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.
- Conditions
- Glioma, Glioblastoma
- Being tested
- Readiband Sleep Tracking
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Readiband Sleep TrackingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Readiband Sleep Tracking | |
| 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. Receives: Device: Readiband Sleep Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participant enrollment to 12 months (or until tumor progression)
Secondary outcomes (4)
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
Measured: Participant enrollment to 12 months (or until tumor progression)
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.
Measured: Participant enrollment to 12 months (or until tumor progression)
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.
Measured: Participant enrollment to 12 months (or until tumor progression)
Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score
Measured: Participant enrollment to 12 months (or until tumor progression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Mar 2018
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Trusheim, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877861
- Sponsor's protocol ID
- NSJT-1701
- Status last verified
- Jun 2021
- First submitted
- 14 Mar 2018
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms in Predicting Cancer Related Fatigue and Diseases Progression in High Grade Glioma
- ClinicalTrials.gov ID
- NCT03877861
- Acronym / sponsor ID
- NSJT-1701
- Conditions
- Glioma, Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Readiband Sleep Tracking - Patient | – | Device: Readiband Sleep TrackingThis 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. |
| Readiband Sleep Tracking - Control | – | Device: Readiband Sleep TrackingAggregate fatigue data and sleep patterns for a group of 30 healthy controls procured from FatigueScience in a de-identified manner for data analysis purposes. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
- 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.
Key exclusion criteria (11 listed)
- Patients enrolled in active clinical treatment trials for primary Grade IV glioma.
- 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.
- Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies).
- Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration.
- Patients with infra-tentorial tumors. vii. Patients with known psychiatric concerns. viii. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Readiband Sleep TrackingOnce 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. | Device | Readiband Sleep Tracking - Control, Readiband Sleep Tracking - Patient |
Primary outcome
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.
4 secondary outcomes
Correlation between SAFTE fatigue predictions and self-reported fatigue levels
Time frame: Participant enrollment to 12 months (or until tumor progression)
Sleep pattern differences between healthy controls and brain tumor patients
Time frame: Participant enrollment to 12 months (or until tumor progression)
Correlation between fatigue and sleep patterns and treatment tolerance/success
Time frame: Participant enrollment to 12 months (or until tumor progression)
Change in Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) score
Time frame: Participant enrollment to 12 months (or until tumor progression)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Trusheim, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Glioblastoma, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between sleep patterns and disease progression/recurrence (time frame: Participant enrollment to 12 months (or until tumor progression)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.