Lee Jie-Eun, Lee Dong Hwa, Oh Tae Jung, Kim Kyoung Min, Choi Sung Hee, Lim Soo, Park Young Joo, Park Do Joon, Jang Hak Chul, Moon Jae Hoon
Department of Internal Medicine, Seoul National University Healthcare System Gangnam Center, Seoul, Republic Of Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Republic Of Korea.
JMIR Res Protoc. 2018 Feb 21;7(2):e49. doi: 10.2196/resprot.8119.
Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis.
The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment.
Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded.
Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017.
This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis.
ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2).
甲状腺毒症是一种由甲状腺激素过多引起的常见疾病。甲状腺毒症的患病率约为2%，其中70 - 90%的病例由格雷夫斯病引起，格雷夫斯病是一种自身免疫性疾病，使用甲巯咪唑或丙硫氧嘧啶等抗甲状腺药物治疗时复发率很高。甲状腺毒症的临床症状和体征包括心悸、体重减轻、烦躁不安和睡眠困难。虽然目前可用的可穿戴活动追踪器能够检测到甲状腺毒症的这些临床变化，但针对甲状腺毒症患者使用可穿戴设备进行临床应用的试验却很少。
本研究的目的是探讨可穿戴设备生成的数据在甲状腺毒症管理中的临床适用性。我们正在分析甲状腺毒症患者治疗后临床过程中持续监测的心率、身体活动和睡眠数据。
30名甲状腺毒症患者和10名对照受试者在首尔国立大学盆唐医院参与了本研究。使用Fitbit Charge HR或Fitbit Charge 2监测心率、身体活动和睡眠情况。记录包括人体测量指标、甲状腺功能测试和甲亢症状量表在内的临床数据。
研究于2016年12月开始入组，干预和随访阶段仍在进行中。数据分析结果预计在2017年9月可得。
本研究将为生物信号测量在甲状腺毒症患者的鉴别诊断、临床病程预测、复发早期检测及治疗中的临床应用提供一项基础可行性试验。
ClinicalTrials.gov NCT03009357；https://clinicaltrials.gov/ct2/show/NCT03009357（由WebCite存档于http://www.webcitation.org/6wh4MWPm2）
