PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Difference in PAP adherence
研究概览
简要总结
The aim of this study is to explore the role of diet/lifestyle intervention on Positive airway pressure (PAP) treatment adherence in patients with obstructive sleep apnea (OSA).Specifically, we evaluated the effects of a combination of PAP and weight-loss Mediterranean diet intervention on improving PAP adherence, Body mass index (ΒΜΙ), daytime symptoms, mainly sleepiness and arterial blood pressure measurements over the effect of standard care alone.
详细描述
We designed a parallel, randomized, controlled, clinical trial. Eligible participants are adult, overweight and obese men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥15 events/h] through an attended overnight polysomnography. Participants, after written informed consent, were blindly randomized to a standard care group (SCG, n=37) and a Mediterranean diet group (MDG, n=37). Study groups were prescribed PAP. The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits, while the MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. PAP adherence (hours of device use), BMI, daytime sleepiness, evaluated by Epworth Sleepiness Scale (ESS) and arterial blood pressure measurements were evaluated pre- and post-intervention.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years with newly diagnosed moderate to severe OSA [apnea-hypopnea index (AHI)≥15 events/h] through an attended overnight polysomnographyaccording to standard criteria
- •overweight and obese [BMI>25 kg/m2]
- •eligible for PAP treatment with adherence data available in the 6-months after initiation of treatment and
- •with an above-elementary school education.
排除标准
- •refusal to participate
- •patients on PAP treatment
- •current participation in a weight loss program
- •central sleep apnea syndromes
- •obesity hypoventilation syndrome
- •restrictive ventilator syndromes
- •severe congestive heart failure
- •a history of life-threatening arrhythmias
- •severe cardiomyopathy
- •long-term oxygen therapy
- •chronic kidney disease
- •family or personal history of mental illness
- •drug or alcohol abuse
- •severe cognitive impairment
- •concurrent oncological diseases
- •pregnancy or lactatio
- •recent hospitalization for acute or chronic respiratory disease
- •history of narcolepsy or restless leg syndrome
结局指标
主要结局
Difference in PAP adherence
时间窗: 6 months
Difference pre post in PAP adherence (hours of device use)
次要结局
- Difference in Body mass index(6 months)
- Difference in Blood pressure measurements(6 months)
- Difference in daytime sleepiness(6 months)
研究者
Izolde Bouloukaki
Clinical Researcher
University of Crete