Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

NCT05669469 | Completed DMC

• 1 other identifier: 66609117.9.0000.0065
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Obesity

Keywords

Sleep Apnea; Obesity; Bariatric Surgery

Outcome Measures

Primary Outcomes (4)

• Upper airway changes after surgical weight loss

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

  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)

  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 %)

  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

  6 months

Secondary Outcomes (1)

• Evaluation if the menstrual status interfere on outcomes

  6 months

Interventions

Bariatric surgery PROCEDURE

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

Also known as: surgical weight loss, Y-Roux

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients were recruited in a center for the treatment of obesity after being referenced by the general practitioner to bariatric surgery. All patients apt for the bariatric surgery have attended weekly multi-professional accompaniment (medical, nursing, nutritional, physiotherapy and psychology) for a 16-week period, being subjected to weight loss through diet counselling, practice of physical activities and changes in life habits. The clinical and polysomnographic evaluations for this study have been carried out between 1 and 7 days before the bariatric surgeries. The magnetic resonance of the upper airways was performed on the eve of the bariatric surgery. At least 6 months after the surgeries, patients underwent a repeated polysomnography and Magnetic Resonance.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michel Burihan Cahali: lead
• Carolina Ferraz de Paula Soares: collaborator

Study Sites (1)

Fundação Hospitalar São Lucas

Cascavel, Paraná, 85812-130, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Michel Cahali, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate supervisor and collaborating professor of Otorhinolaryngology at FMUSP

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 30, 2022
• Study Start: August 15, 2017
• Primary Completion: March 25, 2021
• Study Completion: April 2, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)