Implementation of a 12-week Adapted Physical Activity (APA) Program in People Suffering From Chronic Insomnia.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- objective sleep change
Study Overview
Brief Summary
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.
Detailed Description
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.)
Exclusion Criteria
- •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
Arms & Interventions
control group
no intervention
physical activity
Intervention: physical activity (Behavioral)
Outcomes
Primary Outcomes
objective sleep change
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)