NCT06675344Recruiting
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
A Randomized, Double-blind, Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life (ASScERT-QoL)
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 6 Jan 2025
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Robyn T. Domsic, MD, MPH
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06675344
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 6 Jan 2025 to the primary completion date, 1 Mar 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 8 weeks
- Medication exclusions:
- actively prescribed standing doses of beta-blockers,
- actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Other illness
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Active malignancy
- End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
- Hepatic insufficiency as defined by function worse than Child-Pugh Class B
Other
- Hospitalization for any reason within four weeks of the study baseline visit
- Pregnant or breastfeeding women,
Who the study is looking for
- Age ≥ 18 years
- Ability to provide written informed consent,
- Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
- Baseline score ≥55 on the FACIT-Fatigue scale,
- Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
- Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| DelRicht Research Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| University of Pittsburgh and UPMC Scleroderma Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.