Using Augmented Reality to Establish and Evaluate the Effectiveness of a Set of Continuous Positive Airway Pressure Care Management Protocol for Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The adherence of CPAP therapy
研究概览
简要总结
The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:
Does AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.
Participants will:
- Take AR guided CPAP therapy or standard of care every day for 6 months
- Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).
- Response their symptoms on each following time.
详细描述
Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participnants will be randomly assigned to experimental or control groups by using block randomized method. In the study, we will use independent staff members who are not involved in outcome assessment to handle administrative tasks related to group assignments. In order to mask outcomes assessors, we will ensure that all documents and data sets used by the outcome assessors do not contain any information that could reveal group allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Diagnosed with moderate to severe obstructive sleep apnea (AHI≥15) through polysomnography (PSG).
- •(2) Age is equal to or greater than 20 years old or equal.
排除标准
- •(1) individuals who have previously used positive pressure ventilators for treatment,
- •(2) those diagnosed with central sleep apnea,
- •(3) those with uncontrolled acute mental illness,
- •(4) terminally ill patients.
结局指标
主要结局
The adherence of CPAP therapy
时间窗: From enrollment to the end of treatment at 6 months
Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage.
次要结局
未报告次要终点
研究者
Chen, Yen-Chin
Associate Professor
National Sun Yat-sen University