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RecruitingNCT07878975Updated Oct 16, 2026

HRV Variation in Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis (RA), sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by University of Central Florida · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis (RA)

Keywords

  • Rheumatoid Arthritis
  • Heart Rate Variability
  • Oura ring
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's planned enrollment of 30 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University of Central Florida is the lead sponsor of 104 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients over the age of 18 with a diagnosis of Rheumatoid Arthritis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Main Cohort

    Device: Oura Ring

Interventions

  • DeviceOura Ring

    The Oura ring will be used to continuously monitor HRV.

06

What researchers measure

Primary outcomes

  1. Flare Prediction

    Define prespecified HRV change features and evaluate their association with flare onset using time-varying approaches.

    Time frame: From enrollment to the end of treatment at 6 months

  2. Flare Prediction

    Summarize predictive performance with sensitivity, specificity, PPV/NPV, and ROC/AUC for prespecified thresholds

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. Compare HRV

    Compare HRV between disease activity strata using mixed models

    Time frame: From enrollment to the end of treatment at 6 months

  2. Evaluate HRV

    Evaluate HRV recovery following flare resolution or treatment escalation.

    Time frame: From enrollment to the end of treatment at 6 months

07

Study locations

1 of 1 sites recruiting
  • University of Central Florida
    Orlando, Florida 32827, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878975
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Sep 1, 2026
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Amoy Fraser, PhD, CCRP, PMP
Contact
Amoy.Fraser@UCF.edu
4072668742
Aniya Barclay, MS, BS, CCRP
Contact
aniya.barclay@ucf.edu
4072661554
Shazia Beg, MD
principal investigator · University of Central Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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