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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05669469
Enrollment
38
Registered
2022-12-30
Start date
2017-08-15
Completion date
2022-04-02
Last updated
2022-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Sleep Apnea

Keywords

Sleep Apnea, Obesity, Bariatric Surgery

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.

Interventions

PROCEDUREBariatric surgery

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

Sponsors

Carolina Ferraz de Paula Soares
CollaboratorUNKNOWN
Michel Burihan Cahali
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Upper airway changes after surgical weight loss6 monthsChanges in weight (kilograms) measured before and six months after the bariatric surgery.
Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss6 monthsComparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)
Changes in volumes and areas of upper airway6 monthsChanges through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)
Correlation between the changes on upper airway with the changes on obstructive sleep apnea6 monthsPearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure

Secondary

MeasureTime frameDescription
Evaluation if the menstrual status interfere on outcomes6 monthsParticipants 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026