Recruiting

Observational Study

Sponsor:

University of Central Florida

Code:

NCT07878975

Conditions

Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oura Ring

Study Details

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.

Conditions

Rheumatoid Arthritis (RA)

Study ID

NCT07878975

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Main Cohort

Interventions

Oura Ring

The Oura ring will be used to continuously monitor HRV.

Primary outcome measure

  • Flare Prediction [ Time Frame: From enrollment to the end of treatment at 6 months ]
  • Flare Prediction [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742Amoy.Fraser@UCF.edu

Aniya Barclay, MS, BS, CCRP

4072661554aniya.barclay@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32827

More Information

Sponsor

University of Central Florida

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Rheumatoid Arthritis
  • Heart Rate Variability
  • Oura ring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.