跳至主要内容
临床试验/NCT01102920
NCT01102920已完成不适用

Health Behaviour Modifications in Obstructive Sleep Apnea. Tailored Behavioural Medicine Strategies to Promote Physical Activity and Weight Loss.

Uppsala University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Ventilatory parameters

研究概览

简要总结

The primary aim is to study whether a tailored behavioural medicine intervention addressing physical activity and eating habits have additional effects to continuous positive airways pressure (CPAP) in patients with moderate or severe obstructive sleep apnea syndrome (OSAS) combined with obesity. Direct everyday life consequences (see below) of OSAS are studied, as well as cognitive functions and ventilatory parameters. Long-term benefits will be examined in terms of quality of life and everyday life activity. Another aim is to study mechanisms of treatment effects, if any.

The specific goals are:

  1. To study changes in OSAS ventilatory parameters following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment
  2. To study immediate and long-term effects on daytime sleepiness, attention and concentration, everyday life activity, quality of life following a tailored behavioural medicine intervention addressing physical activity and eating habits (including CPAP) compared to regular CPAP-treatment
  3. To study associations of changes in metabolic parameters and systemic inflammation and physical activity level and adherence to CPAP-regimen respectively.
  4. To identify mediators, moderators, and predictors of treatment effects, if any.

详细描述

OSAS is characterised by loud snoring, upper airway obstruction, and occasional apnea during sleep. OSAS may affect at least 4% of the men and 2% of the women in middle-age. In Sweden, prevalence figures of 200 000 have been reported. The mechanisms behind OSAS is not fully explained but functionally impaired upper airways muscles, causing a reduction in tonic and phasic contraction during sleep, are proposed one key explanation. The reduced contractions cause partial or complete occlusion of airflow, which in turn cause oxygen desaturation and sleep fragmentation. Patients commonly report everyday life consequences including loud snoring, sleep disturbances, daytime sleepiness, reduced alertness and concentration, and involvement in motor vehicle accidents. Between 7% and 70% of patients suffer from depression and anxiety (figures vary extensively because of methodological differences in existing studies). Due to cardiovascular consequences, OSAS is also linked to hypertension, myocardial infarction, and stroke. Approximately 75% of patients with severe OSAS carry overweight. First line measures recommended for OSAS are conservative including lifestyle modifications, CPAP, and oral appliances. Current state-of-science concludes that CPAP is best possible evidence-based treatment. Despite the use of life style modification recommendations in terms of physical activity and weight loss in accepted guidelines of OSAS, randomised clinical trials supporting these recommendations are rare. Hence, the value of health behaviour modifications has yet to be established. Research within this area is therefore of major interest and urgency, which has motivated the present study design.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate or severe obstructive sleep apnea syndrome (AHI/DI>15)
  • Literate in Swedish language

排除标准

  • Physically active patients (walking, bicycling for more than 30 minutes per day,during more than 5 days per week)
  • Cardiovascular diseases including myocardial infarctions and stroke
  • Patients on waiting list for gastric by-pass

研究组 & 干预措施

Tailored behavioural treatment and CPAP

Experimental

Tailored behavioural treatment targeting physical activity and eating habits.

干预措施: Behavioural strategies to promote physical activity and weight loss (Behavioral)

CPAP-treatment

Active Comparator

CPAP-treatment as usual. Advice about benefits of physical activity and weight loss.

干预措施: CPAP (Device)

结局指标

主要结局

Ventilatory parameters

时间窗: Baseline, immediate post-treatment, 18-month follow-up

Ventilatory monitoring at night. Oxygen saturation continuously measured by a pulse oximeter. The following parameters are analysed: * desaturation index * apnoea-hypnoea index * average oxygen saturation during sleep * minimum oxigen saturation * respiration * thoracic respiratory movements * snoring * heart rate * body position

次要结局

  • Attention and concentration(Baseline, immediate post-treatment, 18-month follow-up)
  • Physical activity(Baseline, immediate post-treatment, 18-month follow-up)
  • Functional physical capacity(Baseline, immediate post-treatment, 18-month follow-up)
  • Eating behaviour(Baseline, immediate post-treatment, 18-month follow-up)
  • Anthropometrics(Baseline, immediate post-treatment, 18-month follow-up)
  • Depression(Baseline, immediate post-treatment, 18-month follow-up)
  • Health-related quality of life(Baseline, immediate post-treatment, 18-month follow-up)
  • Patients' priorities of daily activities and participation(Baseline, immediate post-treatment, 18-month follow-up)
  • Daytime sleepiness(Baseline, immediate post-treatment, 18-month follow-up)
  • Self-efficacy and readiness to change behaviour(Baseline, mid-treatment, immediate post-treatment, 18-month follow-up)
  • Fear of movement(Baseline, mid-treatment, immediate post-treatment, 18-month follow-up)
  • Blood sample(Baseline, immediate post-treatment, 18-month follow-up)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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