Rheumatoid Arthritis (RA)
Conditions
Keywords
Rheumatoid Arthritis, Heart Rate Variability, Oura ring
Brief summary
The goal of this observational study is to determine the association between continuous Heart Rate Variability (HRV) measured by the Oura ring and Rheumatoid Arthritis (RA) disease activity.
Interventions
DEVICEOura Ring
The Oura ring will be used to continuously monitor HRV.
Sponsors
University of Central Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RA meeting 2010 ACR/EULAR classification criteria * Seropositive or seronegative RA eligible * Any baseline disease activity (remission/low/moderate/high) to minimize selection bias * Owns a compatible smartphone (iOS/Android) and is willing/able to use the Oura app * Willing to wear Oura Ring during sleep throughout study participation (target adherence ≥5 valid nights/week) * Willing to complete weekly remote assessments and attend baseline and three monthly routine follow-up visits * Able to read and write English language * Able to provide written informed consent
Exclusion criteria
* Atrial fibrillation or other clinically significant arrhythmias expected to invalidate HRV interpretation * Implanted pacemaker/defibrillator where HRV measurements are unreliable * Severe autonomic dysfunction likely to interfere with HRV interpretation (e.g., advanced diabetic autonomic neuropathy), per investigator judgment * Recent major cardiovascular event within 6 months (e.g., myocardial infarction) or uncontrolled heart failure (NYHA class III-IV), per investigator judgment * Current use of beta-blockers (excluded due to known autonomic/HRV effects) * Pregnancy or planned pregnancy during the study period * Inability to wear the ring reliably (e.g., occupational restrictions or hand deformity preventing wear) * Participation in another interventional clinical trial likely to confound outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flare Prediction | From enrollment to the end of treatment at 6 months | Define prespecified HRV change features and evaluate their association with flare onset using time-varying approaches. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare HRV | From enrollment to the end of treatment at 6 months | Compare HRV between disease activity strata using mixed models |
| Evaluate HRV | From enrollment to the end of treatment at 6 months | Evaluate HRV recovery following flare resolution or treatment escalation. |
Countries
United States
Contacts
CONTACTAmoy Fraser, PhD, CCRP, PMP
CONTACTAniya Barclay, MS, BS, CCRP
PRINCIPAL_INVESTIGATORShazia Beg, MD
University of Central Florida
Outcome results
None listed