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临床试验/NCT01289392
NCT01289392已完成不适用

Effects of the Treatment With Continuous Positive Airway Pressure (CPAP) and Oral Appliance, Associated or Not Associated With Physical Exercise, in the Obstructive Sleep Apnea

Associação Fundo de Incentivo à Pesquisa2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年10月1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
25
试验地点
2
主要终点
Objective Sleep Parameters

研究概览

简要总结

Introduction: It is unclear whether exercise training with or without Continuous Positive Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.

Objective: In patients with moderate OSA, the investigators will evaluate the effect on the subjective and objective measures of sleep, quality of life and mood of different forms of treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP and OA; treatment with CPAP and treatment with OA.

Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9) will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE; n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete two months of treatment with CPAP or OA to examine the separate effects of these devices. As the patients of the E group did not use the CPAP but will undergo four months of exercise training. After this initial step, patients in CE and AE groups will undergo four months of exercise training associated with CPAP or OA. The investigators will evaluate the subjective sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries) and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of Mood States (POMS) and anthropometric measurements (neck circumference and body composition), the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).

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 (Investigator)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male subjects aged between 25 and 65 years old
  • Sedentary according to the criteria of Godin and Shephard (1985) and / or ACSM (2000)
  • Epworth Sleepiness Scale over score of nine
  • Normal range of laboratory tests [blood count, cholesterol, High-density lipoprotein (HDL), triglycerides, fasting glucose, creatinine, Thyroid-stimulating hormone (TSH)]
  • Lung function test (spirometry), chest X-ray (for smokers and former smokers) electrocardiogram (rest and stress) and ENT examination without significant changes

排除标准

  • Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders
  • Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP
  • Loss of posterior dental support to undermine the retention of oral appliance
  • Active periodontal disease, compared Dental crown / dental root less than or equal to 1 (c / r ≤ 1), need for primary dental care (cavities, root canal treatment or retreatment, dentures, ie outlying), open bite
  • Protrusive displacement less than five millimeters
  • Limited mouth opening (would prevent the forming of the dental arches)
  • Alcoholism
  • Uuse of sleep-inducing medications
  • Habits or occupations that lead to sleep deprivation or alteration of the sleep-wake cycle
  • Inability to perform physical exercise, regular history sports activities
  • Intolerance to Continuous Positive Airway Pressure (CPAP)
  • Obesity grade II (moderate) and III (severe)

结局指标

主要结局

Objective Sleep Parameters

时间窗: 6 months after the basal evaluation

Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

Sleep Apnea

时间窗: 6 months

Number of events per hour of sleep

次要结局

  • Inflammatory Markers(6 months after the basal evaluation)

研究者

发起方
Associação Fundo de Incentivo à Pesquisa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Lia Azeredo-Bittencourt

professor

Associação Fundo de Incentivo à Pesquisa

研究点 (2)

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