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HRV Variation in Rheumatoid Arthritis

Heart Rate Variability as a Continuous Digital Biomarker for Flare Activity Monitoring and Flare Resolution in Rheumatoid Arthritis: A Pilot Study Using the Oura Ring

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether changes in the time between heartbeats are linked to how active rheumatoid arthritis (RA) is. RA is a disease that causes joint swelling and pain. The study is for people with RA who can wear an Oura ring to track their heartbeats during sleep.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have RA that meets the 2010 ACR/EULAR rules for identifying RA.
  • Can have RA with or without certain blood markers.
  • Can have any level of RA activity, including no active symptoms.
  • Own a compatible iPhone or Android phone and be willing and able to use the Oura app.
  • Be willing to wear the Oura ring during sleep throughout the study, aiming for at least 5 nights of usable readings each week.
  • Be willing to complete weekly check-ins from home, a starting visit, and 3 monthly follow-up visits.
  • Be able to read and write English.
  • Be able to give written consent to join.

Who can't join

  • Have atrial fibrillation or another serious uneven heartbeat that would make the ring's readings hard to interpret.
  • Have an implanted pacemaker or defibrillator that makes the heartbeat readings unreliable.
  • Have severe damage to nerves that control automatic body functions, such as heartbeat, that could affect readings, as judged by the study doctor.
  • Have had a major heart or blood vessel event, such as a heart attack, in the past 6 months, or have uncontrolled, severe heart failure, as judged by the study doctor.
  • Currently take beta-blockers, medicines that can affect heart rate and the study's readings.
  • Are pregnant or plan to become pregnant during the study.
  • Cannot wear the ring regularly, such as because of work rules or hand shape changes.
  • Are in another study testing a treatment that could affect this study's results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

FL