Using a wearable device to improve symptoms in systemic sclerosis patients
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)
This study is testing if wearing a special device can help people with systemic sclerosis feel less tired and manage their symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 4 sites (New Orleans, Louisiana and 3 other locations) |
| Trial ID | NCT06675344 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Apollo Neuro device in managing fatigue and Raynaud phenomenon in patients with systemic sclerosis (SSc). It is a randomized, sham-controlled trial involving 160 participants who will wear either the Apollo device or a sham device daily for six weeks. The primary outcomes focus on improvements in quality of life as reported by the patients, specifically targeting the symptoms that most significantly affect their daily living. The device provides transcutaneous vibratory stimulation and is designed to be worn on the wrist or ankle.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with systemic sclerosis who experience significant fatigue and Raynaud phenomenon.
Not a fit: Patients with a history of sympathectomy, recent Botox injections, diabetes, or active malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could offer a new non-pharmacologic treatment option for SSc patients to alleviate debilitating symptoms and enhance their quality of life.
How similar studies have performed: While the specific use of the Apollo device in SSc is novel, similar non-pharmacologic interventions have shown promise in managing symptoms in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Ability to provide written informed consent,
3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
4. Baseline score ≥55 on the FACIT-Fatigue scale,
5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
6. 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
7. Currently owns and operates an iOS or Android smart phone regularly
8. Ability to comply with the clinical visits schedule and the study-related procedures.
Exclusion Criteria:
1. History of sympathectomy or stellate ganglion block
2. History of Botox injections to the digits within the last 3 months
3. Diabetes mellitus
4. Major surgery within 8 weeks
5. Hospitalization for any reason within four weeks of the study baseline visit
6. Active malignancy
7. Pregnant or breastfeeding women,
8. End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B
10. Medication exclusions:
1. actively prescribed standing doses of beta-blockers,
2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Where this trial is running
New Orleans, Louisiana and 3 other locations
- DelRicht Research Center — New Orleans, Louisiana, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Pittsburgh and UPMC Scleroderma Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Robyn T Domsic, MD — University of Pittsburgh
- Study coordinator: Maureen M Laffoon, BS
- Email: laffoonm@pitt.edu
- Phone: 412-648-7871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.