Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Obesity Clinical Trial

Official title:

Upper Airway of Women With Obstructive Sleep Apnea Changes After Bariatric Surgery and a Possible Influence of Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05669469
• Other study ID #: 66609117.9.0000.0065
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: April 2, 2022

Study information

• Verified date: December 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2, 2022
• Est. primary completion date: March 25, 2021
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Bariatric surgery
1) gastric pouch creation, 2) creation of biliopancreatic limb, 3) jejunojejunostomy creation, and 4) creation of gastrojejunostomy.

Locations

Country	Name	City	State
Brazil	Fundação Hospitalar São Lucas	Cascavel	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Michel Burihan Cahali	Carolina Ferraz de Paula Soares

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper airway changes after surgical weight loss	Changes in weight (kilograms) measured before and six months after the bariatric surgery.	6 months
Primary	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)	6 months
Primary	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 %)	6 months
Primary	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	6 months
Secondary	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	6 months