Last reviewed · How we verify
NCT03701737: GOUSAS
Study of Eating Behaviour and Sense of Taste Before and After Treatment With Nocturnal Continuous Positive Airway Pressure in Overweight Patients With Obstructive Sleep Apnea Syndrome.
trial testing questionnaires in Obesity in 94 participants. Completed in 30 January 2023.
30 January 2023
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire Dijon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 94 |
| Start date | 25 February 2019 |
| Primary completion | 30 January 2023 |
| Estimated completion | 30 January 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- questionnaires
- wrist actimeter
- Blood samples — full drug profile →
Conditions studied
- Obesity — all drugs for Obesity →
- Obstructive Sleep Apnoea Syndrome — all drugs for Obstructive Sleep Apnoea Syndrome →
Sponsor
Centre Hospitalier Universitaire Dijon
Who can join
18 and older, any sex, with Obesity or Obstructive Sleep Apnoea Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03701737
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03701737 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire Dijon
- Last refreshed: 29 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03701737.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing