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

Официальное название

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)

Обзор

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.

Подробное описание

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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Вмешательства

• Устройство 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 mini
• Устройство 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.

Первичные конечные точки

• Change in fatigue [Срок оценки: Baseline, 6 Weeks]
• Change in average weekly Raynaud attacks [Срок оценки: Baseline, 6 Weeks]

Вторичные конечные точки (9)

• Change in quality of life [Срок оценки: baseline up to week 6]
• Change in Raynaud phenomenon symptom severity [Срок оценки: baseline to week 6]
• Change in the Raynaud Condition Score [Срок оценки: baseline to week 6]
• Change Sleep [Срок оценки: change from baseline to week 6]
• Change in pain [Срок оценки: baseline to week 6]
• Change in depression [Срок оценки: change baseline to week 6]
• Change in Social Function [Срок оценки: baseline to week 6]
• Change in dysautonomia symptoms [Срок оценки: baseline to week 6]
• Change in pain intensity [Срок оценки: baseline to week 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• DelRicht Research Center — New Orleans
• University of Michigan — Ann Arbor
• University of Pittsburgh and UPMC Scleroderma Center — Pittsburgh
• Vanderbilt University Medical Center — Nashville

Публикации

• 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. PMID 36214062

Идентификаторы

NCT: NCT06675344 · STUDY24040026 · HT94252410456

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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