We will study subjects with morbid obesity, considered nutritional and metabolic disease, undergone bariatric surgery, for investigation of sleep disorders, especially obstructive sleep apnea.
Conditions
Interventions
Subjects morbid obese undergone bariatric surgery will be asked to participe in the study. All the subjects' evaluations will occur prior to the surgical intervention and 30, 90 and 360 days following
procedure/surgery
Sponsors
Universidade Nove de Julho - UNINOVE
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Grade III morbid obesity (BMI between 40 and 55 kg/m²) or between 35 and 39 kg/m² with comorbidities; Both gender patients aged 18 to 65 years; Documented history of conventional weight loss attempts having proven unsuccessful over time; Agreement to participate in the study through a signed term of informed consent.
Exclusion criteria
Exclusion criteria: Any medical condition rendering surgery too risk; Clinically significant or unstable mental health concerns; Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment; Smokers (at least 8 weeks prior to surgery), abusive alcohol use and/or drugs use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea/hypopnea index by standard overnight polysomnography. Sleep study will be performed with an standard overnight polysomnography monitoring system recording EEG, EMG and EOG, thoracic and abdominal movements by strain gauges, oro-nasal airflow by thermistor, snoring, body position, heart rate by cardiotachography, and pulse oximetry. An apnea was defined as the absence of airflow for more than 10 seconds and classified as central in the absence of thoraco-abdominal movements. Hypopnea was defined as a 50% decrease of airflow and thoraco-abdominal movements with a consensual oxyhaemoglobin desaturation, and classified as central hypopnea in the absence of paradoxical movements of thorax and abdomen. ;Slope of ventilatory response to carbon dioxide performed by spirometry. The rebreathing test was performed according to Read technique. Patients breathed through a mouthpiece and, after a steady state was achieved, basal ventilation was recorded for three minutes. Then patients started to breath connected to a 15 L latex balloon filled with a 7% CO2 and 93% O2 mixture for five minutes or until an end-tidal CO2 pressure PetCO2 of 70 mm Hg was reached or until exhaustion. Data were acquired by a metabolic cart (Vmax 29c, Sensor Medics, USA) and the slope of ventilatory response to carbon dioxide was obtained from the linear regression between ventilation and PetCO2. Data were adjusted by a 0.9 correction factor to correct flow readings for hyperoxic gas mixture. | — |
Secondary
| Measure | Time frame |
|---|---|
| The measurements of waist and neck circumference at physical exam. ;Thorax and abdomen cirtometry at physical exam. ;Maximal inspiratory pressure and maximal expiratory pressure evaluated by digital manovacuometer. ;Evaluation of diurnal sleepiness intensity by the Epworth Sleepiness Scale.; Evaluation of the risk to obstructive sleep apnea through Berlin Questionn;Evaluation of quality of life, weight loss percentage and changes in medical conditions through the Bariatric Analysis and Reporting Outcome System (Baros).;Weight loss evaluated by Body mass index.;Sleep physiological variables assessed by the standart overnight polysomnography. | — |
Countries
Brazil
Contacts
Public ContactLuis Vicente;Luis Vicente Oliveira;Oliveira
Universidade Nove de Julho - UNINOVE;Universidade Nove de Julho - UNINOVE
Outcome results
None listed