Using a wearable device to improve symptoms in systemic sclerosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of the Apollo Neuro device in managing fatigue and Raynaud phenomenon in patients with systemic sclerosis (SSc). It is a randomized, sham-controlled trial involving 160 participants who will wear either the Apollo device or a sham device daily for six weeks. The primary outcomes focus on improvements in quality of life as reported by the patients, specifically targeting the symptoms that most significantly affect their daily living. The device provides transcutaneous vibratory stimulation and is designed to be worn on the wrist or ankle.

Why it matters

Who can join: the full rules

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.

Where it's running

• DelRicht Research Center
  New Orleans, Louisiana, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• University of Pittsburgh and UPMC Scleroderma Center
  Pittsburgh, Pennsylvania, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Robyn T Domsic, MD — University of Pittsburgh
• Study coordinator: Maureen M Laffoon, BS
• Email: laffoonm@pitt.edu
• Phone: 412-648-7871

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.