Clinical trial

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.

Name
GEORGES APJ 2017
Description
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.
Trial arms
Trial start
2019-02-25
Estimated PCD
2023-01-30
Trial end
2023-01-30
Status
Completed
Treatment
questionnaires
* VAS on the feeling of hunger * Evaluation of food wanting by the Finlayson test * PREFQUEST Questionnaire * 24-hour food recall * Stunkard Questionnaire * Measurement of daytime sleepiness by Epworth score
wrist actimeter
Actimeter delivery: it is worn on the wrist for 7 days, 24 hours a day.
Blood samples
2 dry tubes of 7 ml of blood collected at each visit for plasma assays (ghrelin, leptin, FGF 21, amino acids including tryptophan, insulin resistance)
Size
94
Primary endpoint
food wanting by Finlayson's standardized computerized test
Day 0 and 45
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 94, 'type': 'ACTUAL'}}
Updated at
2023-09-29

1 organization

1 product

2 indications

Indication
Obesity