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NCT03360565: OBANEZ
Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery
trial in Obesity in 130 participants. Status unknown.
2 March 2018
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 130 |
| Start date | 2 March 2016 |
| Primary completion | 2 March 2018 |
| Estimated completion | 2 March 2020 |
| Sites | 1 location across France |
Conditions studied
- Obesity — all drugs for Obesity →
- Bariatric Surgery — all drugs for Bariatric Surgery →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Obesity or Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial is a monocentric, prospective, observational and controlled trial (historical cohort control group of healthy non-obese subjects who had Nasal functional exploration for Snoring) as part of current care. This study concerns the prevalence of obstructive sleep apnea syndrome (OSAS). OSAS is elevated in subjects with morbid obesity (BMI≥40) (on average 70%). International recommendations agree on the need to seek OSAS before bariatric surgery because of the high risk of complications. Increased nasal resistance could also be related to a limitation of inspiratory flow due to an abnormality of the elasticity of the nasal mucosa or "nasal compliance". Adipose infiltration of the nasal mucosa may occur during obesity. These tissue changes (decreased vaso-erectile tissue and increased adipose tissue) could modify the nasal compliance, which the decrease would be a possible factor of severity of OSAS in obese patients. Screening for an abnormality of compliance could also anticipate a difficulty of equipment for Continuous Positive Airway Pressure (CPAP) in the case of associated OSAS. All patients who must have bariatric surgery and get in the criteria are included. They will have to do a medical checkup pre and post-operative (polygraphy + ear/nose/throat assessment (ENT) + Nasal functional exploration). They will be followed for 13 to 24 months. The main objective of this research is to demonstrate a reduction of at least 30% of nasal compliance in a group of obese subjects (BMI\> 35) compared to a control group of healthy subjects. The secondary objectives are to is to demonstrate an increase of 30% in resistance in patients with BMI\> 35 compared to control group and a normalization of nasal compliance 1 year after surgery when their weight is normalized (BMI \<30). A study period of 4 years is planned.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03360565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT03360565 (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 Assistance Publique - Hôpitaux de Paris
- Last refreshed: 4 December 2017
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/NCT03360565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing