Apollo Device for Fatigue in Systemic Sclerosis

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 improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time (Siegle & Rabin et al., under review). Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy.

A total of 30-40 patients will be enrolled and followed for 1 month, with baseline data collected before using Apollo and follow-up data collected after using the device. This clinical trial is open-label, meaning that all participants will receive Apollos and no placebos will be used. All participants will be allowed to continue underlying immunosuppressive and Raynaud therapy at stable doses during the trial. Since this is a pilot study, future larger controlled trials will be necessary to clearly demonstrate drug effectiveness.

At study registration there was an oversight and we did not include the secondary outcome of number of weekly Raynaud attacks. Raynaud visual analog scale (VAS) was not a secondary outcome measure.

Inclusion criteria

• 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 criteria

• 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