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临床试验/NCT05294133
NCT05294133Unknown不适用

Implementation of a 12-week Adapted Physical Activity (APA) Program in People Suffering From Chronic Insomnia.

Universite du Littoral Cote d'Opale1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
objective sleep change

研究概览

简要总结

One third of men and women are not satisfied with their sleep. A non-drug countermeasure to improve sleep in insomniacs could be adapted physical activity (APA). However, research is needed because the literature is limited and the few studies are most often based on subjective data with a great methodological disparity. Within the framework of the care pathway of Dr ARON's patients, sleep doctor at the Sommeil Morphée Center of the Grande Synthe Polyclinic (59), the objective of this project is to make an APA program more reliable in order to improve sleep, to understand the underlying mechanisms and to include APA in the therapeutic management.

详细描述

According to the 2019 National Sleep and Vigilance Institute survey, in France, one-third of men and women are not satisfied with their sleep, and nearly half struggle to fall asleep or return to sleep. Given the growing evidence of the harmful effects of lack of sleep, its alteration on health, these figures are alarming.

Insomnia is characterized by dissatisfaction with the quantity or quality of sleep, difficulty initiating and/or maintaining sleep, and early morning awakenings at least three times a week for a minimum period of three months.

In a Sleep Medicine Reviews report, it was shown that many patients diagnosed with insomnia had a physiological hyperarousal disorder that resulted in poor sleep, which has been found in insomniacs in numerous studies. It is observed in particular on the autonomic nervous system by a low variability of heart rate and a high level of noradrenaline reflecting a dominant sympathetic axis. An anxiogenic and depressive profile and elevated cortisol levels are also often associated with this hyperarousal encountered in insomniacs. In addition, an alteration of the circadian rhythm seems to favor insomnia. Indeed, a decrease in core temperature and cortisol levels in the evening are primary mechanisms for sleep onset. A study showed an elevated sleep latency in individuals with this delayed circadian temperature rhythm. In the same study, a high wake-up time after sleep was associated with a high core temperature. Regarding cortisol, a smaller decline in cortisol and higher cortisol levels at the end of the day are associated with shorter sleep duration, lower sleep efficiency, and poor subjective sleep quality.

Although a first treatment of insomnia would be to find a good lifestyle and optimal sleep conditions, the majority of first-line remedies in the treatment of insomnia remain pharmacological today, through the short- or medium-term prescription of hypnotics, neuroleptics, anxiolytic benzodiazepines or some antidepressants.

If the practice of regular physical activity is now well known to improve overall health, what about sleep?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women aged 18 to 60 with chronic insomnia (according to the 5 criteria of the Diagnostic and Statistical Manual) without any other associated sleep pathology (sleep apnea, restless legs syndrome, etc.)

排除标准

  • •Medical contraindication to physical activity Associated serious medical pathologies (cancer...) Night work, jet lag during the last month, young children BMI> 30 Current use or <3 months of psychoactive, hypnotic, stimulant or analgesic medications Alcohol or drug abuse

研究组 & 干预措施

control group

No Intervention

no intervention

physical activity

Experimental

干预措施: physical activity (Behavioral)

结局指标

主要结局

objective sleep change

时间窗: before and after the 12 weeks

Participants were fitted with an accelerometer on their wrist (non-dominant arm) for 7 days to assess the quantity and quality of their sleep

subjective sleep change

时间窗: before and after the 12 weeks

questionnaire insomnia severity index. The minimum score is 0 and the maximum is 28. Higher scores mean a worse outcome. A score higher than 14 is considered as a person with clinical insomnia.

次要结局

  • objective stress change(before and after the 12 weeks)
  • physical capacity change(before and after the 12 weeks)
  • circadian rythm change(before and after the 12 weeks)
  • subjective stress change(before and after the 12 weeks)
  • hearth rate variability change(before and after the 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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