A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint
研究概览
简要总结
The investigators hope to learn the feasibility and preliminary efficacy of the Embr device for improving thermal comfort in individuals with POTS and impaired thermoregulation. Feasibility will be assessed via usage of the Embr device and participant feedback. Preliminary efficacy measures will include temperature-related symptoms and temperature- related quality of life in individuals with POTS and impaired thermoregulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of POTS
- •Participant self-report of heat or cold intolerance
- •Willingness to wear the Embr device for 3 weeks, charging the device daily, and
- •Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater
- •Comfortable downloading and using the companion app on their phone
- •Able to provide informed written consent
- •Able to complete written questionnaires
排除标准
- •Prior or current use of the study device
- •Hypohidrosis, hyperhidrosis, or anhidrosis, as determined by sudomotor testing; peripheral neuropathy; perimenopausal, menopausal, postmenopausal state; temperature intolerance due to other medical disorders (i.e. malignancy, systemic autoimmune disease)
- •Medications known to affect sweat function
- •Non-English speaking
研究组 & 干预措施
Embr Watch
Participants will receive the device and a technical onboarding video 3 days prior to study start to allow time for familiarization with the device and troubleshooting any technical questions or problems prior to study start. The study will consist of baseline measurements prior to using the Embr device and weekly outcome assessments at Week 1, 2, 3, and 4
干预措施: Embr Device (Device)
结局指标
主要结局
Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint
时间窗: Baseline and end of study ( 4 weeks)
Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.
Temperature Quality of life Questionnaire
时间窗: Week 1,2,3,4
Temperature related daily interference scale
时间窗: Week 1,2,3,4
Scale range is 0-100, with a higher score indicating more problems with thermoregulation.
OCEAN Temperature Related Psychogenic Questionnaire
时间窗: Week 1,2,3,4
Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint
时间窗: Baseline and end of study ( 4 weeks)
PSQI score ranges in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values.
Change from baseline in Compass-31 survey at study endpoint
时间窗: Baseline and end of study ( 4 weeks)
Compass 31 score ranges in value from 0 to 100. A score of 0 indicates no autonomic symptoms, while more-severe autonomic symptoms correspond to higher values.
次要结局
未报告次要终点
研究者
Mitchell Miglis
Clinical Assistant Professor, Neurology and Neurological Sciences
Stanford University