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Could a Smartwatch-Like device ease scleroderma symptoms?

NCT ID NCT06675344

Symptom relief Sponsor: Robyn T. Domsic, MD, MPH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a wearable device called Apollo Neuro can reduce fatigue and Raynaud's attacks in people with systemic sclerosis (scleroderma). The device delivers gentle vibrations to the skin. 160 participants will wear it daily for 6 weeks and report their symptoms. The goal is to improve quality of life without medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apollo Neuro wearable device (transcutaneous vibratory stimulation)
What this could lead to
If it works, this could offer a drug-free way to manage fatigue and Raynaud attacks in people with scleroderma.
What could go wrong
This is a small, early-stage trial testing a device, not a cure. The benefits may be modest or not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Ability to provide written informed consent, 3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA 4. Baseline score ≥55 on the FACIT-Fatigue scale, 5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40, 6. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline 7. Currently owns and operates an iOS or Android smart phone regularly 8. Ability to comply with the clinical visits schedule and the study-related procedures. Exclusion Criteria: 1. History of sympathectomy or stellate ganglion block 2. History of Botox injections to the digits within the last 3 months 3. Diabetes mellitus 4. Major surgery within 8 weeks 5. Hospitalization for any reason within four weeks of the study baseline visit 6. Active malignancy 7. Pregnant or breastfeeding women, 8. End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis, 9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B 10. Medication exclusions: 1. actively prescribed standing doses of beta-blockers, 2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma Fatigue Raynaud disease systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • DelRicht Research Center

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh and UPMC Scleroderma Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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