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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in fatigue
研究概览
简要总结
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.
详细描述
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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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Apollo Neuro Device
Apollo Neuro Device
干预措施: Apollo Neuro Device (Device)
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.
干预措施: Sham device (Device)
结局指标
主要结局
Change in fatigue
时间窗: 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
时间窗: 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.
次要结局
- Change in quality of life(baseline up to week 6)
- Change in Raynaud phenomenon symptom severity(baseline to week 6)
- Change in the Raynaud Condition Score(baseline to week 6)
- Change Sleep(change from baseline to week 6)
- Change in pain(baseline to week 6)
- Change in depression(change baseline to week 6)
- Change in Social Function(baseline to week 6)
- Change in dysautonomia symptoms(baseline to week 6)
- Change in pain intensity(baseline to week 6)
研究者
Robyn T. Domsic, MD, MPH
Associate Professor of Medicine
University of Pittsburgh