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

Study acronym: ASScERT-QoL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 1 to 4v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2024 to Jan 6, 2025
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06675344
Lead Sponsor Robyn T. Domsic, MD, MPH
Collaborators: United States Department of Defense
Conditions
(from sponsor)
Systemic Sclerosis (SSc)
Related terms Fatigue, Raynaud Disease, Scleroderma, Diffuse, Scleroderma, Systemic
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov