Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Completed

• Conditions: Obesity; Sleep Apnea

• Registration Number: NCT05669469
• Lead Sponsor: Michel Burihan Cahali

Brief Summary

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

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 Timeline

• Study Start: 2017-08-15
• Primary Completion: 2021-03-25
• Study Completion: 2022-04-02
• Study First Submitted: 2022-11-12
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in volumes and areas of upper airway	6 months	Changes through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)
Upper airway changes after surgical weight loss	6 months	Changes in weight (kilograms) measured before and six months after the bariatric surgery.
Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss	6 months	Comparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)
Correlation between the changes on upper airway with the changes on obstructive sleep apnea	6 months	Pearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure

Secondary Outcome Measures

Name	Time	Method
Evaluation if the menstrual status interfere on outcomes	6 months	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

Trial Locations

Locations (1)

Fundação Hospitalar São Lucas; 🇧🇷 Cascavel, Paraná, Brazil