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Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

NCT ID: NCT05669469

Last Updated: 2022-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-15

Study Completion Date

2022-04-02

Brief Summary

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Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.

Detailed Description

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The the present study aims at describing the modifications occurring in the upper airway (UA) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (OSA). The hypothesis is that the massive weight loss after bariatric surgery on OSA women could modify the UA more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of UA after bariatric surgery.

Conditions

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Sleep Apnea Obesity

Keywords

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Sleep Apnea Obesity Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bariatric surgery

1\) gastric pouch creation, 2) creation of biliopancreatic limb, 3) jejunojejunostomy creation, and 4) creation of gastrojejunostomy.

Intervention Type PROCEDURE

Other Intervention Names

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surgical weight loss Y-Roux

Eligibility Criteria

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Inclusion Criteria

* patients with a recommendation and considered apt for bariatric surgery by the multi-professional group
* aged between 18 and 70
* with a residual (after the 16-week period) BMI above 35 kg/m2
* polysomnographic obstructive sleep apnea diagnosis: Apnea-Hypopnea Index (AHI) above 5 events per hour associated with a co-morbidity and/or complaints of snoring.

Exclusion Criteria

* patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (MR)
* carrying metal artifacts which contraindicate the performing of MR
* patients with a history of pharyngeal or neoplasia in the head and neck region
* patients affected by gross craniofacial deformities
* pregnant women
* previous UA surgery for OSA
* patients undergoing any other treatment for OSA.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Carolina Ferraz de Paula Soares

UNKNOWN

Sponsor Role collaborator

Michel Burihan Cahali

OTHER

Sponsor Role lead

Responsible Party

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Michel Burihan Cahali

Postgraduate supervisor and collaborating professor of Otorhinolaryngology at FMUSP

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michel Cahali, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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Fundação Hospitalar São Lucas

Cascavel, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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66609117.9.0000.0065

Identifier Type: -

Identifier Source: org_study_id