The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06675344
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Robyn T. Domsic, MD, MPH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robyn T Domsic, MD
Principal Investigator Affiliation	University of Pittsburgh
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Sclerosis (SSc)

Additional Details

Systemic sclerosis (SSc) is a multisystem autoimmune disease that is characterized by progressive vasculopathy, excessive fibrosis, and immune system activation. Fatigue in SSc is common and greatly impacts quality of life: The prevalence of fatigue in SSc patients is significantly higher than the general population. Raynaud phenomenon (RP) in SSc is not only the most common SSc manifestation, affecting nearly all but is often the earliest SSc symptom. SSc-RP is the highest ranked SSc-related symptom affecting quality of life, and is a major cause of SSc-related morbidity. There are currently no approved medications to treat RP, SSc-associated RP phenomenon or fatigue in SSc. Thus, a non-pharmacologic intervention has the potential to provide SSc patients with a new treatment modality without common limiting side effects, and access. The Apollo wearable provides transcutaneous vibratory stimulation, and can be worn on the wrist or ankle. Goal: To recruit 160 SSc patient participants into this randomized, sham-device controlled clinical trial. Patients will be randomized 1:1 to receive the Apollo vs.#46; sham wearable, which they will wear daily for 6 weeks. Outcome measures focus on quality-of-life. .

Arms & Interventions

Arms

Experimental: Apollo Neuro Device

Apollo Neuro Device

Sham Comparator: Sham Device

Study participants will be randomized 1:1 (Apollo Neuro device : Sham device) Devices are identical; however, the sham device will be set to a frequency that has no therapeutic benefits.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UPMC Arthritis and Autoimmunity Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Arthritis and Autoimmunity Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Maureen Laffoon, BS

[email protected]

412-648-7871

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