Clinical trial NCT05669469: Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery
Official title: Upper Airway of Women With Obstructive Sleep Apnea Changes After Bariatric Surgery and a Possible Influence of Menopause
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Obesity
Keywords: Sleep Apnea
Obesity
Bariatric Surgery
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Carolina Ferraz de Paula Soares
First posted: 2022-12-30
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper airway changes after surgical weight loss
timeFrame: 6 months
measure: Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss
timeFrame: 6 months
measure: Changes in volumes and areas of upper airway
timeFrame: 6 months
measure: Correlation between the changes on upper airway with the changes on obstructive sleep apnea
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation if the menstrual status interfere on outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Cascavel
country: Brazil
facility: Fundação Hospitalar São Lucas
state: Paraná
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Michel Cahali, PhD
role: PRINCIPAL_INVESTIGATOR
References: