N/A
N=25
Apollo Device for Fatigue in Systemic Sclerosis
Systemic Sclerosis · Fatigue · Raynaud Phenomenon
Bottom Line
View on ClinicalTrials.gov: NCT04854850 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline — -7.0; 62.5 T-score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Apollo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robyn T. Domsic, MD, MPH
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) at 4 Weeks (End-of-Study) Compared to Baseline |
-7.0; 62.5 | <0.001 sig |
| SECONDARY Change in Health Assessment Questionnaire-Disability Index (HAQ-DI/SHAQ) at 4 Weeks (End-of-Study) Compared to Baseline |
0.12 | — |
| SECONDARY Change in Total Weekly Raynaud Phenomenon Attacks |
-3.4 | — |
| SECONDARY Change in the Raynaud Condition Score (RCS) at 4 Weeks (End-of-study) From Baseline |
-0.76 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04854850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.