Status:
COMPLETED
Apollo Device for Fatigue in Systemic Sclerosis
Lead Sponsor:
Robyn T. Domsic, MD, MPH
Collaborating Sponsors:
Apollo Neuroscience
Conditions:
Systemic Sclerosis
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
This is a study of the commercially available Apollo Neuro Wellness Device, which is not currently a medical device. The device offers a convenient novel non-invasive, non-habit-forming solution to i...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Men or women aged 18 years and older
- Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
- Baseline T score of 45 on the PROMIS-Fatigue scale.
- Steady daily doses and any immunosuppressive medication, vasodilators, antidepressants and anxiolytic use for 4 weeks prior to baseline.
- Currently owns and operates an iOS or Android smart phone regularly
- Ability to comply with the clinical visits schedule and the study-related procedures.
- Subjects who have struggled with symptoms of SSc (specifically fatigue and Raynauds) who have not received adequate symptom relief from prior treatment attempts (treatment-resistant) will be prioritized.
Exclusion
- Medical and surgical history
- Major surgery within 8 weeks prior to screening
- Participants with an active malignancy.
- End-stage renal disease with an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 (MDRD formula) or on dialysis at the screening visit
- Hepatic insufficiency as defined by the Child-Pugh criteria
- Hospitalization for any reason within four weeks of the study baseline visit.
- History of sympathectomy or stellate ganglion block
- Significant interstitial lung disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
- Pulmonary hypertension with change in medications in the preceding four weeks
- Actively prescribed standing doses of beta-blockers.
- Actively prescribed standing doses of sedatives, hypnotics, opioids, or benzodiazepines.
- Active or unstable psychotic disorder requiring current prescriptions of standing doses of antipsychotic medications
- Active suicidal/homicidal ideation or a suicide or homicide attempt in the past year.
- Pregnant or breastfeeding women
- Other • Any other condition or therapy that would make the participant unsuitable for this study and will not allow participation for the full planned study period
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04854850
Start Date
July 7 2020
End Date
March 15 2023
Last Update
April 2 2025
Active Locations (1)
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1
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213