Clinical trial NCT06270771: OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
Official title: OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: MDS
Myelodysplastic Syndromes
Keywords: transfusion dependent
transfusion independent
OURA ring
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population is in adult patients with MDS. There are no limitations with regards to age or gender.

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.

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, treatment details
* 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* Able to provide informed consent
* Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12)
* Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen
* Willing to operate and charge a smart phone loaded with the OURA ring app

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility of patients with MDS wearing the OURA ring
timeFrame: 3 months
Secondary outcomes:
measure: Exploratory correlations between physiologic changes captured by the wearable device and physical functioning
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Research Centre
state: Ontario
Study officials:
References: