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NCT04854850 · ClinicalTrials.gov registry record · NA
Apollo Device for Fatigue in Systemic Sclerosis
A NA study, sponsored by Robyn T. Domsic, MD, MPH.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT04854850: Completed NA study, sponsored by Robyn T. Domsic, MD, MPH.
NCT04854850 is a NA study that has completed, run by Robyn T. Domsic, MD, MPH. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04854850, a NA study, has completed, sponsored by Robyn T. Domsic, MD, MPH.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.
Primary Outcome
The FACIT-Fatigue is a patient reported outcome of fatigue symptoms, with a score range of 13-65. Low scores indicate low levels of fatigue and high scores indicate high levels of fatigue. A T-score of 50 indicates the population mean with a standard deviation of 10. A lower t-score indicates less fatigue. There are no clinically relevant thresholds.
Interventions
- DEVICE Apollo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2023-03-15 |
| Phase | NA |
What the finished NCT04854850 record still lists
NCT04854850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Apollo is the first listed.
NCT04854850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04854850 about?
NCT04854850 is a clinical study titled "Apollo Device for Fatigue in Systemic Sclerosis". The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feat...
What is the current status of trial NCT04854850?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2020-07-07. Estimated completion is 2023-03-15.
What interventions are being tested in trial NCT04854850?
The interventions under investigation include: Apollo (DEVICE).
Who is sponsoring clinical trial NCT04854850?
This trial is sponsored by Robyn T. Domsic, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04854850's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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