Rheumatoid Arthritis (RA)NCT07878975
HRV Variation in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Oura Ring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 with a diagnosis of Rheumatoid Arthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32827
About this study
Official title: 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
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)
- Being tested
- Oura Ring
- Keywords
- Rheumatoid Arthritis, Heart Rate Variability, Oura ring
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oura RingDevice
The Oura ring will be used to continuously monitor HRV.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Not described Receives: Device: Oura Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flare Prediction
Define prespecified HRV change features and evaluate their association with flare onset using time-varying approaches.
Measured: From enrollment to the end of treatment at 6 months
Flare Prediction
Summarize predictive performance with sensitivity, specificity, PPV/NPV, and ROC/AUC for prespecified thresholds
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Compare HRV
Compare HRV between disease activity strata using mixed models
Measured: From enrollment to the end of treatment at 6 months
Evaluate HRV
Evaluate HRV recovery following flare resolution or treatment escalation.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shazia Beg, MD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878975
- Sponsor's protocol ID
- STUDY00008987
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07878975
- Acronym / sponsor ID
- STUDY00008987
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Heart Rate Variability, Oura ring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Device: Oura Ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 with a diagnosis of Rheumatoid Arthritis
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oura RingThe Oura ring will be used to continuously monitor HRV. | Device | Main Cohort |
Primary outcome
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
2 secondary outcomes
Compare HRV
Time frame: From enrollment to the end of treatment at 6 months
Evaluate HRV
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shazia Beg, MD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amoy Fraser, PhD, CCRP, PMP (4072668742, Amoy.Fraser@UCF.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flare Prediction (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.