Clinical Predictors of Pediatric OSAHS
- Conditions
- Pediatric Sleep Apnea
- Registration Number
- NCT02627937
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
The purpose of this study is to develop adequate and satisfactory tools using reliable clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) and allow greater access to appropriate therapy in children.
- Detailed Description
The prevalence of OSAHS is estimated to be about 1% to 4% in children, however, it is frequently underdiagnosed because of the difficulties for evaluation.Current diagnostic approaches are based on the patient's history, clinical presentation and physical examination, endoscopy, and radiological imaging examinations, and confirmation is made by the current gold standard of full-night polysomnography (PSG). Previous studies have reported the use of a clinical history, physical examination and questionnaires for predicting pediatric OSAHS but there were lacking of adequate and satisfactory results. Despite the potential diagnostic benefits, PSG for pediatric patients are not routinely used in clinical practice. Therefore, to obtain a reliable, valid, and easily-performed diagnostic or screening tool for the clinical assessment of pediatric OSAHS is essential for the cost-effective care of these patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
- children (younger than 18 years old and older than 2 years old) with symptoms of snoring and then were confirmed to having obstructive sleep apnea/hypopnea syndrome by a comprehensive polysomnography
- patients with substance abuse problems or the long-term usage of medications known to affect sleep, craniofacial abnormalities or neuromuscular disorders, Down syndrome, cerebral palsy, mucopolysaccharidoses, Prader-Willi syndrome, history of psychosis, central sleep apnea syndrome, or previous airway surgery including tonsillectomy and/or adenoidectomy were excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical predictors for apnea/hypopnea index (AHI) up to 4 months When all variables were analyzed individually with the AHI, Spearman rank correlation analysis was used to explore the relationships between clinical predictor variables and AHI.Significant variables were entered into stepwise multiple linear regression analysis to identify independent predictors for pediatric OSAHS and to develop a predictive equation for AHI values.
- Secondary Outcome Measures
Name Time Method Anthropometric measurements: tonsil size grading up to 4 months Tonsil size grading: 0, surgically removed tonsils; 1, tonsils hidden within the pillars; 2, tonsils extending to the pillars; 3, tonsils were beyond the pillars but not to the midline; and 4, tonsils extended to the midline.
Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position up to 4 months updated Friedman's tongue position: I: visualization of the entire uvula and tonsils/pillars.; IIa: visualization of most of the uvula, but the tonsils/pillars are absent.; IIb: visualization of the entire soft plate to the base of the uvula.; III: visualization of some of the soft palate, but the distal structures are absent.; IV: visualization of the hard palate only.
Apnea/hypopnea index (AHI) up to 4 months AHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.
Anthropometric measurements: body mass index z-score (BMI z-score) up to 4 months BMI z-score: a measure of relative weight adjusted for the child's age and gender, and calculated by dividing the difference between the measured value and the mean by the standard deviation.
Snoring visual analogue scale (Snoring VAS) up to 4 months Snoring VAS (Units on a Scale): 0-10, 0 = "no snoring noise" and 10 = "the loudest sound imaginable
Anthropometric measurements: uvular length up to 4 months uvular length in centimeter
Trial Locations
- Locations (1)
Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan