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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Bariatric Surgery

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Recruiting
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participation to the study will be proposed to all patients who must have bariatric surgery and have a preoperative assessment

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Emilie BEQUIGNON, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Anticipated): March 2, 2018
• Study Completion (Anticipated): March 2, 2020

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome (OSAS)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Respiratory Insufficiency; Obesity; Airway Obstruction
• Other Study ID Numbers: 2017-A02883-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No