NCT07878975 · University of Central Florida
HRV Variation in Rheumatoid Arthritis
What this study is about
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.
View original scientific description
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
DEVICE
Oura Ring
The Oura ring will be used to continuously monitor HRV.
Primary outcome measures
Flare Prediction
Time frame: 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.
Flare Prediction
Time frame: From enrollment to the end of treatment at 6 months
Summarize predictive performance with sensitivity, specificity, PPV/NPV, and ROC/AUC for prespecified thresholds
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations