ObesityOBANEZNCT03360565
Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery
An observational study of Obesity and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participation to the study will be proposed to all patients who must have bariatric surgery and have a preoperative assessment
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obstructive Sleep Apnea Syndrome (OSAS)
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before bariatric surgery
Secondary outcomes (2)
To demonstrate an increase of 30% in resistance in patients with BMI> 35 compared to control group
Measured: before bariatric surgery
To demonstrate a normalization of nasal compliance when the weight is normalized (BMI <30)
Measured: 9 month (+3month) after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Mar 2016
- Primary completion2 Mar 2018 (estimated)
- Study completion2 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie BEQUIGNON, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360565
- Sponsor's protocol ID
- 2017-A02883-50
- Acronym
- OBANEZ
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery : A Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT03360565
- Acronym / sponsor ID
- OBANEZ / 2017-A02883-50
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obstructive Sleep Apnea Syndrome (OSAS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 2 Mar 2018 (estimated)
- Study completion
- 2 Mar 2020 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participation to the study will be proposed to all patients who must have bariatric surgery and have a preoperative assessment
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: before bariatric surgery
2 secondary outcomes
To demonstrate an increase of 30% in resistance in patients with BMI> 35 compared to control group
Time frame: before bariatric surgery
To demonstrate a normalization of nasal compliance when the weight is normalized (BMI <30)
Time frame: 9 month (+3month) after bariatric surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie BEQUIGNON principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie BEQUIGNON, PH ((0)1 49 81 24 91 ext. +33, emilie.bequignon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: before bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.