Obesity Clinical Trial - Obesity: Prospective Evaluation of Upper Airway

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03360565
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Emilie BEQUIGNON, PH
Phone	(0)1 49 81 24 91
Email	emilie.bequignon@gmail.com
Status	Recruiting
Phase	N/A
Start date	March 2, 2016
Completion date	March 2, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms