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临床试验/NCT04623463
NCT04623463招募中不适用

Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift in Patients Who Can't Use CPAP or MAD

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
2
主要终点
Apnea-Hypopnea index

研究概览

简要总结

Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction.

Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently.

A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions.

The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level.

Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patient aged 18 to 80 years old
  • Patient with OSA (AHI ≥ 15 events/hr)
  • Patient not receiving any treatment for their OSA
  • Patient able to provide written informed consent
  • Patient able to participate in regular physical activity (no medical contraindication to exercise)

排除标准

  • • Pregnancy
  • Person deprived of liberty or subject to a legal protection measure
  • Patient presenting a condition that can influence the results. (According to the investigator's judgment, i.e. heart failure, venous insufficiency).
  • Vulnerable person or legally protected adult.
  • Patients already included in another interventional study
  • BMI > 30 kg/m²
  • Patient taking diuretics

结局指标

主要结局

Apnea-Hypopnea index

时间窗: Baseline-4weeks

Measured during polysomnography

次要结局

  • Subjective sleepiness as measured by the Epworth Sleepiness Score(Baseline-4weeks)
  • Overnight change in leg fluid volume(Baseline-4weeks)
  • Quality of life assessed by the SF-36 questionnaire(Baseline-4weeks)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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