Adherence of Health Coaching with Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Oxygen Desaturation Index (ODI)
研究概览
简要总结
The goal of this clinical trial is to learn how integrating health and wellness coaching (HWC) with Continuous Positive Airway Pressure (CPAP) therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea. The main questions it aims to answer are:
- Does HWC improve CPAP adherence compared to standard care, in terms of device usage metrics (hours per night and days per month)?
- How does combining HWC with weight management influence CPAP adherence and weight loss?
- What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC?
Researchers will compare two groups:
- Standard Care Group: Participants receiving standard CPAP therapy without additional health coaching.
- HWC Group: Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene.
Participants will:
- Attend 2 in-office visits with a study physician (2 hours maximum)
- Have 6 virtual visits via video with a study health coach (3 hours maximum) if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy.
详细描述
Purpose:
The purpose of this research study is to compare the effects of a wearable sleep ring combined with health coaching in the STANDARDCARE (STAND) group to a CONTROL (CON) group with no sleep ring and no health coaching. The investigators aim to see if this combination improves patient satisfaction and progress with using a CPAP machine.
Procedures:
If participants agree to participate, they will be asked to do the following:
Baseline Assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Individuals will be randomized to the intervention or control at the baseline. SAS version 9.4 will be used to create the randomization list.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Both genders
- •All ethnicities
- •Must reside in the state of TN
- •Newly diagnosed with obstructive sleep apnea (OSA)
- •Prescribed with moderate to severe OSA.7). AHI of > 15
排除标准
- •Unable or unwilling to use wearable device,
- •end stage renal failure
- •heart failure or stroke
- •Although not anticipated for this study population, women cannot be or suspect they may be pregnant.
结局指标
主要结局
Oxygen Desaturation Index (ODI)
时间窗: Daily for 90 days
The ODI is a measurement that helps diagnose and manage obstructive sleep apnea (OSA) by quantifying how often and how much a person's blood oxygen level drops during sleep.
Quality-of-life survey responses
时间窗: Through Study Completion, an average of 3 months
Quality-of-life survey responses assess an individual's overall well-being, encompassing physical, mental, and social health.
次要结局
未报告次要终点