The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Recruiting N/A Interventional Study
Systemic Sclerosis (SSc)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
160 (estimated)
Sponsor
Robyn T. Domsic, MD, MPH · Other
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About This Trial

The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.

Trial Locations
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Eligibility Criteria
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-sco…
Contacts

Maureen M Laffoon, BS

412-648-7871

laffoonm@pitt.edu

CONTACT

Robyn T Domsic, MD

412-647-6700

rtd4@pitt.edu

CONTACT