Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Michel Burihan Cahali38 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep Apnea Obesity

Interventions

Bariatric surgeryPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fundação Hospitalar São Lucas

Cascavel, Paraná, Brazil

Outcomes

Primary Outcomes

Upper airway changes after surgical weight loss

Changes in weight (kilograms) measured before and six months after the bariatric surgery.

Time frame: 6 months

Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss

Comparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)

Time frame: 6 months

Changes in volumes and areas of upper airway

Changes through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)

Time frame: 6 months

Correlation between the changes on upper airway with the changes on obstructive sleep apnea

Pearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure

Time frame: 6 months

Secondary Outcomes

Evaluation if the menstrual status interfere on outcomes

Participants are divided between menses and menopause groups; evaluation of the changes occurred on weight (kilograms), upper airway measures (millimeters and percentages) and polysomnographic (apnea hypopnea indexes) are different according menstrual status

Time frame: 6 months

Data from ClinicalTrials.gov

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