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临床试验/NCT03701737
NCT03701737已完成不适用

Study of Eating Behaviour and Sense of Taste Before and After Treatment With Nocturnal Continuous Positive Airway Pressure in Overweight Patients With Obstructive Sleep Apnoea Syndrome.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
food wanting by Finlayson's standardized computerized test

研究概览

简要总结

Obstructive sleep apnea (OSA) is characterized by a repeated partial or complete obstruction of the airway that results in a intermittent hypoxia and sleep disturbance.

A complex and reciprocal link between obesity and OSA exists. On the one hand, obesity is one of the main risk factors for OSA. On the other hand, OSA seems to promote obesity. The changes in sleep patterns that characterize OSA alter energy metabolism and promote weight gain. In particular, OSA is associated with metabolic disturbances, decreased physical activity and changes in energy expenditure resulting in weight gain. OSA is characterized by resistance to leptin which reduces the feeling of satiety and an increase in ghrelin levels which increases the feeling of hunger.

There may be an increase in food intake, but very few studies have looked at this aspect. Our current knowledge is based on simple patient reports of the amount of food consumed per 24 hours.

First-line treatment of OSA is based on continuous positive airway pressure (CPAP) but this approach is not curative and weight loss is encouraged. CAPP could facilitate weight loss by restoring sleep quality. Paradoxically, recent studies show weight gain proportional to the duration of use of CPP. Randomized controlled trials offering apneic patients a return to physical activity and hygiene-dietary rules have shown an improvement in OSA after weight loss.

A better understanding of the influence of OSA and its treatment on the energy balance through food preferences and olfacto-gustatory sensoriality is an essential prerequisite for personalized nutritional management. In the face of unexpected weight gain under CPP, this type of intervention would be all the more beneficial as OSA and obesity are public health problems representing two independent risk factors for cardiovascular morbidity and mortality with increasing incidence.

We hypothesize that the treatment of OSA with CPAP changes food preferences in favour of fatty and sugary high-calorie foods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patient with moderate to severe OSA (apnea and hypopnea index > 15/h) for whom a CPAP is indicated
  • Obese patient (body mass index > 30 kg/m2)
  • Adult Patient
  • Patient who has given oral consent
  • Patient speaks and reads French
  • Patient affiliated to a the national health insurance system

排除标准

  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a measure to judiciary protection
  • Pregnant, parturient or breastfeeding woman
  • Major unable or unwilling to consent
  • Psychiatric, cognitive or neurological disorders making it impossible to assess food preferences
  • Eating disorders (anorexia, bulimia)
  • Patient suffering from an acute infection, progressive cancer or under treatment interfering with taste (anti-cancer, antibiotics...)
  • Patient consuming alcohol daily
  • Patient who smokes actively or has quit for less than 6 months
  • Weight change of more than 10% in body weight in the six months before inclusion

结局指标

主要结局

food wanting by Finlayson's standardized computerized test

时间窗: Day 0 and 45

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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