OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study

ConditionsMDS Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms RARS-T

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Performance status ECOG > 3.

Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

OURA Ring
Device
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Transfusion Dependent1 intervention

Group B: Transfusion Independent1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

3 months

Secondary outcomes

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

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

Source ClinicalTrials.gov

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