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NCT06675344 · ClinicalTrials.gov registry record · NA
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
A NA study of Systemic Sclerosis (SSc), sponsored by Robyn T. Domsic, MD, MPH.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 4
- Study locations
NCT06675344: Recruiting NA study of Systemic Sclerosis (SSc), sponsored by Robyn T. Domsic, MD, MPH.
NCT06675344 is a NA study of Systemic Sclerosis (SSc) that is actively recruiting participants, run by Robyn T. Domsic, MD, MPH. The registered enrollment target is 160 participants, above the 82-participant average among 8 other Systemic Sclerosis (SSc) trials with a reported enrollment target (95% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06675344, a NA study of Systemic Sclerosis (SSc), is actively recruiting participants, sponsored by Robyn T. Domsic, MD, MPH.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
The PROMIS® (Patient-Reported Outcomes Measurement Information System) SF v1.0 Fatigue 13a scale. This is a13-item, patient reported measure of an individual's level of fatigue during their usual daily activities over the past week. The raw score is converted to a T-score for analysis with 50 for the mean and a standard deviation of 10.
Conditions Studied
Interventions
- DEVICE Sham device
- DEVICE Apollo Neuro Device
Study Locations (4)
Louisiana
- DelRicht Research Center - New Orleans
Michigan
- University of Michigan - Ann Arbor
Pennsylvania
- University of Pittsburgh and UPMC Scleroderma Center - Pittsburgh
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-01-06 |
| Est. Completion | 2028-09 |
| Phase | NA |
What NCT06675344 shows while recruiting
NCT06675344 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 8 other Systemic Sclerosis (SSc) trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Systemic Sclerosis (SSc) appearing as the primary indexed condition, and to 2 interventions - of which Sham device is the first listed.
NCT06675344 reports a single indexed study location in Louisiana, Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06675344 about?
NCT06675344 is a clinical study titled "The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life". 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...
What is the current status of trial NCT06675344?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2025-01-06. Estimated completion is 2028-09.
What conditions does trial NCT06675344 study?
This clinical trial studies the following conditions: Systemic Sclerosis (SSc).
What interventions are being tested in trial NCT06675344?
The interventions under investigation include: Sham device (DEVICE), Apollo Neuro Device (DEVICE).
Who is sponsoring clinical trial NCT06675344?
This trial is sponsored by Robyn T. Domsic, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06675344 being conducted?
This trial has 4 study locations across Louisiana, Michigan, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis (SSc)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06675344's enrollment target sits among peer trials
160 2nd of 8 the highest of 8 other Systemic Sclerosis (SSc) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis (SSc) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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