Obstructive Sleep Apnea Respiratory Tract Diseases
Conditions
Interventions
Prospective observational study with 600 participants, distributed as follows: Group 1: 75 adults (18-69 years) without Cleft Lip and Palate and without Obstructive Sleep Apnea – control group
Group 2: 75 adults (18-69 years) without Cleft Lip and Palate and with Obstructive Sleep Apnea – control group
Group 3: 75 children (0-17 years) without Cleft Lip and Palate and without Obstructive Sleep Apnea – control group
Group 4: 75 children (0-17 years) without Cleft Lip and Palate and with Obstructive Sleep Apnea – control group
Group 5: 75 adults (18-69 years) with Cleft Lip and Palate and without Obstructive Sleep Apnea – experimental group
Group 6: 75 adults (18-69 years) with Cleft Lip and Palate and with Obstructive Sleep Apnea – experimental group
Group 7: 75 children (0-17 years) with Cleft Lip and Palate and without Obstructive Sleep Apnea – experimental group
Group 8: 75 children (0-17 years) with Cleft Lip and Palate and with Obstructive Sleep Apnea – experimental group. All groups will undergo a standardized multimodal assessment: polygraphy (types III a
Sponsors
Universidade de São Paulo
Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) da Universidade de São Paulo (USP)
Eligibility
Age
No minimum to 69 Years
Inclusion criteria
Inclusion criteria: Maximum age 69 years (adult group – from 18 to 69 years, pediatric group – from 0 to 17 years); both sexes
Exclusion criteria
Exclusion criteria: Having systemic diseases or cognitive impairments that contraindicate the examinations or may compromise the validity of the examination results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether the prevalence and severity of obstructive sleep apnea (OSA) differ significantly between individuals with and without cleft lip and palate (CLP), with OSA being more prevalent and more severe among individuals with CLP | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find differences in the prevalence and severity of Obstructive Sleep Apnea (OSA) between children and adults, with a possible increase in severity in adults with Cleft Lip and Palate (CLP). Type IV polygraphy is effective and comparable to type III, enabling technical agreement analysis, as a more practical and reliable alternative for clinical use and for home-based diagnosis of Obstructive Sleep Apnea (OSA);To evaluate the utility of the Pediatric Sleep Questionnaire (PSQ) in children and the BERLIN questionnaire in adults for estimating the risk of Obstructive Sleep Apnea (OSA), especially when compared to data obtained by polysomnography;It is expected to establish a possible correlation between Body Mass Index (BMI), body composition, circumferences and blood pressure with the risk of Obstructive Sleep Apnea (OSA), determined by the questionnaires and confirmed by polysomnography, especially in groups with Cleft Lip and Palate (CLP);It is expected to demonstrate the cardiovascular repercussions of Obstructive Sleep Apnea (OSA), especially in adults with Cleft Lip and Palate (CLP), in whom greater severity of Obstructive Sleep Apnea (OSA) and worsening of cardiovascular parameters are expected to be observed;To evaluate that the upper airways of individuals with Cleft Lip and Palate (CLP) and Obstructive Sleep Apnea (OSA) present smaller volumes and minimum cross-sectional areas in relation to individuals without Cleft Lip and Palate (CLP), suggesting an anatomical predisposition to Obstructive Sleep Apnea (OSA);It is expected to establish a high correlation between volumetric data obtained from rhinopharyngometry and tomography, allowing the validation of rhinopharyngometry as a practical and radiation-free alternative for measuring the airways;To evaluate the reduced airway dimensions with greater severity of Obstructive Sleep Apnea (OSA), allowing the identification of anatomical profiles associated with greater predisposition to Obstructive | — |
Countries
BR
Contacts
Public ContactIvy Trindade Suedam
Universidade de São Paulo
Outcome results
None listed