NCT06675344 · Robyn T. Domsic, MD, MPH
The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
(ASScERT-QoL)
What this study is about
The purpose of this study it to test the effectiveness of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomly assigned trial.
View original scientific description
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.
Interventions
DEVICE
Apollo Neuro Device
The Apollo Neuro wearable device is an Apple Watch-sized wearable device that delivers vibration at set frequencies , termed transcutaneous vibratory stimulation, or TVS. These low volume sound waves feel like a soothing touch to the skin (TVS) and activate touch receptors. Apollo is controlled via smartphone and worn on the wrist or ankle. The Apollo is fitted with an adjustable band, made of a durable neoprene material with polyester overlays. Participants are asked to wear it daily for a minimum time period for 6 weeks. Users can choose from different modes of vibration, with some being energizing, others relaxing.
DEVICE
Sham device
The Apollo Neuro is an Apple Watch-sized wearable device that delivers vibration, termed transcutaneous vibratory stimulation, or TVS. The sham device is identical in appearance to the active intervention, but provides a lower frequency vibration that has no known therapeutic benefit.
Primary outcome measures
Change in fatigue
Time frame: Baseline, 6 Weeks
The PROMIS® (Patient-Reported Outcomes Measurement Information System) SF v1.0 Fatigue 13a scale. This is a13-item, patient reported measure of an individual's level of fatigue during their usual daily activities over the past week. The raw score is converted to a T-score for analysis with 50 for the mean and a standard deviation of 10.
Change in average weekly Raynaud attacks
Time frame: Baseline, 6 Weeks
Average number of weekly Raynaud attacks. Over a period of one week, patients will record their Raynaud phenomenon (RP) attack frequency via a smartphone app. The Raynaud app is usable on both Apple iPhones and Android phones.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
- Active malignancy
- Pregnant or breastfeeding women,
- 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
- Medication exclusions:
- actively prescribed standing doses of beta-blockers,
- actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
Where
- New Orleans, Louisiana
- Ann Arbor, Michigan
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations