RecruitingNot ApplicableNCT06675344

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)

Sponsor

Robyn T. Domsic, MD, MPH

Enrollment

160 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Sclerosis (SSc)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria12

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.

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Interventions

DEVICEApollo 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.

DEVICESham 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.