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

NCT06270771 | Recruiting

• 1 other identifier: 5823
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months.

Conditions

MDS; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; RARS-T

Keywords

transfusion dependent; transfusion independent; OURA ring

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Exploratory correlations between physiologic changes captured by the wearable device and physical functioning

  2 years

Study Arms (2)

Transfusion Dependent

Patients who are currently receiving transfusions will be assigned to this cohort

Device: OURA Ring

Transfusion Independent

Patients who are not currently receiving transfusions will be assigned to this cohort

Device: OURA Ring

Interventions

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.

Transfusion Dependent; Transfusion Independent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Performance status ECOG \> 3.
• Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Research Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Dr. Rena Buckstein, MD

CONTACT

416-480-5000; rena.buckstein@sunnybrook.ca

Mohammed Siddiqui

CONTACT

416-480-5000; mohammed.siddiqui@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: March 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)