Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery

Obesity Clinical Trial

— OBANEZ  

Official title:

Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery : A Monocentric Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360565
• Other study ID #: 2017-A02883-50
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2017
• Last updated: November 28, 2017
• Start date: March 2, 2016
• Est. completion date: March 2, 2020

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emilie BEQUIGNON, PH
• Phone: (0)1 49 81 24 91
• Email: emilie.bequignon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Voluntary Patient

• Patients aged 18 years or older.

• BMI > 35

• Patient included in the bariatric surgery protocol

• Medical checkup :polygraphy and Respiratory Functional Exploration (RFE)

Exclusion Criteria:

• Impossible to obtain a consent or age less than 18 years

• Heart / Kidney Failure

• Absence of affiliation to a Social Security scheme

• History of rhinological surgery

• Pregnancy, Breastfeeding

• Subject presenting a congenital or acquired obstructive nasal obstructive physical obstacle (obstructive deviation, craniofacial malformation)

Related Conditions & MeSH terms

• Airway Obstruction
• Bariatric Surgery
• Obesity

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		before bariatric surgery
Secondary	To demonstrate an increase of 30% in resistance in patients with BMI> 35 compared to control group		before bariatric surgery
Secondary	To demonstrate a normalization of nasal compliance when the weight is normalized (BMI <30)		9 month (+3month) after bariatric surgery