Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Sleep Apnea
• Intervention / Treatment: Procedure: Bariatric surgery

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Cascavel, Paraná, Brazil, 85812-130
      • Fundação Hospitalar São Lucas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Michel Burihan Cahali
• Collaborators: Carolina Ferraz de Paula Soares
• Investigators: Principal Investigator: Michel Cahali, PhD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): April 2, 2022

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Sleep Apnea; Bariatric Surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 66609117.9.0000.0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: as described in the informed consent form, the data collected in the research would not be shared with the patients, but they could, at the end of the study, request copies of the tests performed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No