MDSOURA MDSNCT06270771
OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
An observational study of MDS and Myelodysplastic Syndromes, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDS, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- What is being tested?
- OURA Ring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 Adult patients with MDS of which 30 are transfusion-dependent and 30 are non-transfusion dependent. There are no limitations with regards to age or gender.
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used)
- Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12) all risk groups
- Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen
Who cannot join
- Performance status ECOG > 3.
- Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Research Centre
Toronto, Ontario, M4N 3M5
Rena Buckstein, 416-480-5000 ext. 689565, rena.buckstein@sunnybrook.ca
Geetha Yogendran, 416-480-5000 ext. 689565, geetha.yogendran@sunnybrook.ca
About this study
A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months.
Read the detailed description
This is a single-centre feasibility study involving two groups of patients (transfusion-dependent MDS and non-transfusion dependent MDS), each enrolling 30 patients. Eligible patients who consent to the study will be provided with the OURA ring sizing kit to determine their ring size. Baseline characteristics will be collected, including the following information if available:
- 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.
- Being tested
- OURA Ring
- Keywords
- transfusion dependent, transfusion independent, OURA ring
- Medical subject headings
- Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OURA RingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion Dependent | Patients who are currently receiving transfusions will be assigned to this cohort Receives: Device: OURA Ring | |
| Transfusion Independent | Patients who are not currently receiving transfusions will be assigned to this cohort Receives: Device: OURA Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of patients with MDS wearing the OURA ring
Feasibility will be defined as being worn 70% of the time and uploaded to a web-based database weekly x 3 months.
Measured: 3 months
Secondary outcomes (1)
Exploratory correlations between physiologic changes captured by the wearable device and physical functioning
Correlation between self-rated fatigue, physical functioning with steps taken, calories burned/day, sleep, readiness scores; Correlation between resting heart rate, heart rate variability, respiratory rate, oxygen saturation with hemoglobin, transfusion dependence, dates of transfusion, and unplanned healthcare encounters
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Mar 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270771
- Sponsor's protocol ID
- 5823
- Acronym
- OURA MDS
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
- ClinicalTrials.gov ID
- NCT06270771
- Acronym / sponsor ID
- OURA MDS / 5823
- Keywords
- transfusion dependent, transfusion independent, OURA ring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Feb 2024 (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.
A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months.
Detailed description
This is a single-centre feasibility study involving two groups of patients (transfusion-dependent MDS and non-transfusion dependent MDS), each enrolling 30 patients. Eligible patients who consent to the study will be provided with the OURA ring sizing kit to determine their ring size. Baseline characteristics will be collected, including the following information if available:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfusion Dependent | – | Device: OURA RingPatients who are currently receiving transfusions will be assigned to this cohort |
| Transfusion Independent | – | Device: OURA RingPatients who are not currently receiving transfusions will be assigned to this cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 Adult patients with MDS of which 30 are transfusion-dependent and 30 are non-transfusion dependent. There are no limitations with regards to age or gender.
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used)
- Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12) all risk groups
Key exclusion criteria (2 listed)
- Performance status ECOG > 3.
- Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.
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 |
|---|---|---|
| OURA RingThe 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. | Device | Transfusion Dependent, Transfusion Independent |
Primary outcome
Feasibility of patients with MDS wearing the OURA ring
Time frame: 3 months
Feasibility will be defined as being worn 70% of the time and uploaded to a web-based database weekly x 3 months.
1 secondary outcome
Exploratory correlations between physiologic changes captured by the wearable device and physical functioning
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- 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.
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 MDS and Myelodysplastic Syndromes, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rena Buckstein, MD (416-480-5000 ext. 5847, rena.buckstein@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of patients with MDS wearing the OURA ring (time frame: 3 months). 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 8 Jul 2025.