Clinical trial NCT06675344: The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Sclerosis (SSc)
Keywords: Scleroderma
Raynaud Phenomenon
fatigue
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-11-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind, sham device-controlled trial.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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. sham wearable, which they will wear daily for 6 weeks.

Outcome measures focus on quality-of-life.

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Eligibility 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.

Primary outcomes:
measure: Change in fatigue
timeFrame: Baseline, 6 Weeks
measure: Change in average weekly Raynaud attacks
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: baseline up to week 6
measure: Change in Raynaud phenomenon symptom severity
timeFrame: baseline to week 6
measure: Change in the Raynaud Condition Score
timeFrame: baseline to week 6
measure: Change Sleep
timeFrame: change from baseline to week 6
measure: Change in pain
timeFrame: baseline to week 6
measure: Change in depression
timeFrame: change baseline to week 6
measure: Change in Social Function
timeFrame: baseline to week 6
measure: Change in dysautonomia symptoms
timeFrame: baseline to week 6
measure: Change in pain intensity
timeFrame: baseline to week 6
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Arthritis and Autoimmunity Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robyn T Domsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu L, Domsic RT, Saketkoo LA, Withey J, Frech TM, Herrick AL, Hummers LK, Shah AA, Denton CP, Khanna D, Pauling JD. Assessment of the Systemic Sclerosis-Associated Raynaud's Phenomenon Questionnaire: Item Bank and Short-Form Development. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1725-1734. doi: 10.1002/acr.25038. Epub 2023 Jan 30.