OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
NCT ID: NCT06270771
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2025-03-20
2027-02-01
Brief Summary
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Detailed Description
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* Patient demographics such as age, sex, history of cancer
* MDS disease characteristics: date of diagnosis, IPSS and IPSS-R score, transfusion status, transfusion schedule, MDS specific treatment and concomittent medications
* Laboratory data: hemoglobin, MCV, RDW, WBC, reticulocyte count, creatinine clearance, bilirubin, ALT, AST, LDH, ferritin
The correctly sized OURA ring will be ordered and provided to the patient within 4 weeks during their Baseline visit at "week 0". At this time, technological assistance will be provided for correctly wearing the ring, installation of the OURA app to their smartphone, and teaching the patient how to sync the OURA ring to their device. During this visit, patients will have their first clinical assessment which includes a physical exam, vitals, height and weight, as well as the 4-metre walk test and the administration of the study questionnaires (ECOG score, clinical frailty score, QLQ-C30, QUALMS, EQ-5D, global fatigue scale, and the Lawton-Brody instrumental activity of daily living (IADL) scale.
Patients will be given study forms to take home and complete based on the schedule listed in Appendix A. This includes a daily log of their global fatigue score, and a section for descriptive annotation of significant events in the day. Once every 7 days, patients will fill in the QLQ-C30, PROMIS-fatigue, QUALMS physical functioning subscale and synchronize the OURA ring data onto their smartphone.
Patients will have monthly follow-up appointments at 1 and 2 months into the study. At these times, clinical events in the month will be reviewed, including whether they had transfusions, hospitalizations, or major health events. Patients' OURA ring data will be reviewed. Depending on OURA ring results, the physician involved may determine to order additional investigations or referrals (such as sleep clinic assessment or cardiology referrals).
At month 3, patients will have their study exit visit. Data from the OURA ring app will be downloaded and a debrief will occur to qualitatively gauge the experience of a wearable device.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transfusion Dependent
Patients who are currently receiving transfusions will be assigned to this cohort
OURA Ring
The OURA ring (https://ouraring.com) is a light-weight wearable device in the form of a ring that has several microsensors enabling detection of heart rate, blood oxygen level, skin temperature, and movement. The OURA ring and application can synthesize the sensory data to generate physiologic information such as sleep, activity level, resting heart rate, heart rate variability, respiratory rate, and more. The OURA ring is water resistant and has up to 5-7 days of battery life and can be fully charged in 20-80 minutes. It communicates with the OURA app and commonly used Smartphone health apps via Bluetooth connectivity with automatic syncing every week.
Transfusion Independent
Patients who are not currently receiving transfusions will be assigned to this cohort
OURA Ring
The OURA ring (https://ouraring.com) is a light-weight wearable device in the form of a ring that has several microsensors enabling detection of heart rate, blood oxygen level, skin temperature, and movement. The OURA ring and application can synthesize the sensory data to generate physiologic information such as sleep, activity level, resting heart rate, heart rate variability, respiratory rate, and more. The OURA ring is water resistant and has up to 5-7 days of battery life and can be fully charged in 20-80 minutes. It communicates with the OURA app and commonly used Smartphone health apps via Bluetooth connectivity with automatic syncing every week.
Interventions
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OURA Ring
The OURA ring (https://ouraring.com) is a light-weight wearable device in the form of a ring that has several microsensors enabling detection of heart rate, blood oxygen level, skin temperature, and movement. The OURA ring and application can synthesize the sensory data to generate physiologic information such as sleep, activity level, resting heart rate, heart rate variability, respiratory rate, and more. The OURA ring is water resistant and has up to 5-7 days of battery life and can be fully charged in 20-80 minutes. It communicates with the OURA app and commonly used Smartphone health apps via Bluetooth connectivity with automatic syncing every week.
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or older
4. Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used)
5. Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12) all risk groups
6. Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen
Exclusion Criteria
2. Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Locations
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Sunnybrook Health Sciences Research Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5823
Identifier Type: -
Identifier Source: org_study_id
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