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NCT Number: NCT05669469

Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Fundação Hospitalar São Lucas

Cascavel, Paraná, 85812-130, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

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

Other names: surgical weight loss, Y-Roux

Primary outcomes

  1. Upper airway changes after surgical weight loss

    Time frame: 6 months

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

  2. Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss

    Time frame: 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)

  3. Changes in volumes and areas of upper airway

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Secondary outcomes

  1. Evaluation if the menstrual status interfere on outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Michel Burihan Cahali

Other

Collaborators

  • Carolina Ferraz de Paula Soares

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 30, 2022
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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