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临床试验/NCT03202602
NCT03202602已完成不适用

The Benefits of Telemedicine in CPAP Treatment of Obstructive Sleep Apnea Syndrome (OSAS)

Uppsala University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2017年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
CPAP adherence

研究概览

简要总结

Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving a good treatment effect, and early intervention if treatment problems emerge is important for achieving good adherence, information on patient compliance is usually based on assessment of the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could therefore be an option allowing for adequate support and quick response if a patient has problems with the treatment. In addition, improving early experiences of CPAP, identifying patients in need of more intensive support could potentially improve adherence but also reduced cost of care, and increased patient satisfaction.

The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients randomized to afterwards receiving telemonitoring in combination with telephone calls, and 100 patients randomized to receiving usual office visits. All patients will in addition answer questionnaires on sleep and health, quality of life, and patient satisfaction after the first CPAP information visit and then again after 6 months of treatment. At time of follow-up all patients will also answer questionnaires on side effects of CPAP. Health economic variables will also be measured throughout the testing period.

The study will provide valuable information regarding benefits of telemonitoring in clinical work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may be an important part of increasing adherence among patients but also in the development of a more cost-effective care as it can provide clinics with increased treatment capacity and follow-up of both new and established patients. It would further improve the care for these patients who often have a lifelong treatment, which aims to reduce the risk of developing cardiovascular disease or premature death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with OSA and scheduled to receive CPAP treatment

排除标准

  • Patients not understandning Swedish
  • Patients not eligible for CPAP start within a group session.

结局指标

主要结局

CPAP adherence

时间窗: 6 months

Time of CPAP use at follow-up. Assesed from count in CPAP machine.

次要结局

  • Duration of visits/contacts.(6 months)
  • Patient satisfaction regarding CPAP treatment and contact with clinic(6 months)
  • Number of visits/contacts.(6 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Theorell-Haglöw

Principal Investigator

Uppsala University

研究点 (1)

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