Apollo for Fatigue

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh School of Medicine, Pittsburgh, PA
Fatigue+6 More
Apollo - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Apollo Device for Fatigue in Systemic Sclerosis

See full description

Eligible Conditions

  • Fatigue
  • Systemic; Sclerosis, Progressive
  • Raynaud's Phenomenon

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fatigue

Study Objectives

This trial is evaluating whether Apollo will improve 1 primary outcome and 3 secondary outcomes in patients with Fatigue. Measurement will happen over the course of Change in FACIT-Fatigue from baseline to 4 weeks.

Week 4
Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline
Week 4
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline
Week 4
The Median Change in the Raynaud Phenomenon Visual Analog Scale (RP-VAS) Score at 4 Weeks (End-of-study) Compared to Baseline
From baseline to 4-week follow-up
Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline

Trial Safety

Safety Progress

1 of 3

Other trials for Fatigue

Trial Design

1 Treatment Group

Apollo
1 of 1
Experimental Treatment

This trial requires 27 total participants across 1 different treatment group

This trial involves a single treatment. Apollo is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Apollo
Device
Participants will all receive Apollo devices.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in haq-d1/shaq from baseline to 4 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in haq-d1/shaq from baseline to 4 weeks for reporting.

Who is running the study

Principal Investigator
R. T. D.
Prof. Robyn T. Domsic,, MD
University of Pittsburgh

Closest Location

University of Pittsburgh School of Medicine - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Someone who takes a steady daily dose of immunosuppressive medication, vasodilators, antidepressants, or anxiolytics for 4 weeks prior to baseline is likely to have a significant change in their anxiety levels. show original
Currently has an iPhone or Android smartphone that they use frequently. show original
People with SSc who have not received relief from treatment will be given priority for new treatments. show original
Systemic sclerosis is a disease that is diagnosed based on certain criteria that are set by the American College of Rheumatology and the European Union League Against Rheumatism show original
Being able to attend the clinical visits on schedule and comply with any study-related procedures. show original
The individual has a baseline T score of 45 on the PROMIS-Fatigue scale. show original
Signed written informed consent
Men or women aged 18 years and older

Patient Q&A Section

Is apollo typically used in combination with any other treatments?

"The use of Apollo in conjunction with conventional and alternative therapies has not appeared to be as popular as the use of Apollo without a combination." - Anonymous Online Contributor

Unverified Answer

What is raynaud disease?

"Raynaud disease is essentially a symptom of endothelial dysfunction. The term 'Raynaud disease' has been used more commonly than what it actually is. As such, the use of 'Raynaud disease' in medical literature to describe a range of conditions is still a problem and deserves review." - Anonymous Online Contributor

Unverified Answer

What causes raynaud disease?

"Raynaud's disease is not associated with exposure to certain chemicals, nor with tobacco use or occupational exposures. Moreover, it is not associated with psychological factors, or the immune system or endocrine system. It most likely has a complex pathogenesis, involving the sympathetic autonomic system, the immune system, and the nervous system." - Anonymous Online Contributor

Unverified Answer

What are the signs of raynaud disease?

"This patient-reported survey has shown that patients with RD have a variety of symptoms. Asymmetry can be important with RD but is often overlooked. Most often, patients present with symptoms of vasospasm causing the lower limbs to swell after exercise. This can be a powerful indication of vasospasm and a cause of significant discomfort. While it has been recognised that smoking can make the symptoms worse, erythema rileyi can develop after cessation of smoking and so smoking cessation may be indicated. Moreover, vasospasm is more common in men than women and a physical examination of the lower limbs may indicate a blood clot, further causing an exacerbation of vasospasm." - Anonymous Online Contributor

Unverified Answer

How many people get raynaud disease a year in the United States?

"Around 1 million more people will be diagnosed with Raynaud's disease in the United States during the year 2030 than have been diagnosed by 2009, primarily due to more frequent testing, increased awareness and diagnosis of silent disease, and expanded use of vasoactive medications." - Anonymous Online Contributor

Unverified Answer

What are common treatments for raynaud disease?

"Surgical revascularization procedures for RD are extremely rare, and surgical treatment for these patients with symptomatic RVD is nearly nonexistent. However many patients with RVD have a history of major vascular, endoscopic or surgical procedures such as kidney transplant and coronary interventions. These patients may be candidates, but not patients, for revascularization treatment. These data should be emphasized to patients, family physicians and dermatologists." - Anonymous Online Contributor

Unverified Answer

Can raynaud disease be cured?

"Raynaud's disease cannot be cured by external means. However, the arterial blood pressure is regulated by an active norepinephrine reserve in the kidneys and can be restored to normality by surgical removal of suprarenal fat." - Anonymous Online Contributor

Unverified Answer

How does apollo work?

"Treatment with apollo is safe and effective with no side effects for patients who have a wide spectrum of phenotypes of CHN. Patients who have symptoms of mild CHN may benefit from short bouts of apollo to prevent progression." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in apollo for therapeutic use?

"For a number of indications, apollo is an effective and promising tool for the therapy of patients with severe cardiovascular disorders. These data provide a basis for further evaluation of apollo for the purpose of treating apnoea of prematurity and heart failure in neonates. This report also establishes apollo as a tool for long-term treatment of cardiovascular disorders. The development of apollo as a therapeutic agent also provides further justification for the clinical evaluation of apollo as a therapeutic tool for coronary artery disease." - Anonymous Online Contributor

Unverified Answer

What does apollo usually treat?

"It may be difficult to find clinical trials specifically for patients with RHD but several studies on patients with RHD have been conducted so it may be helpful for those with specific questions to ask." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of apollo?

"While this is not a randomized study there appear to be an increased risk of venous hypertension during the course of treatment with apollo. Apollo can cause thrombophlebitis or hematoma. Other side effects include hypertension, fatigue and insomnia. It is recommended that women with a history of venous hypertension consider regular consultations with their doctor, particularly if they are treated with other oral drugs." - Anonymous Online Contributor

Unverified Answer

Has apollo proven to be more effective than a placebo?

"apollo is an effective agent in inducing and maintaining long-term BP control in patients with Raynaud disease who require continuous BP lowering. Results from a recent paper establishes this agent as a promising treatment in this patient population." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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