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Clinical Trials/NCT02627937
NCT02627937
Unknown
Not Applicable

Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome

Chang Gung Memorial Hospital1 site in 1 country88 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Sleep Apnea
Sponsor
Chang Gung Memorial Hospital
Enrollment
88
Locations
1
Primary Endpoint
Clinical predictors for apnea/hypopnea index (AHI)
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Clinical predictors for apnea/hypopnea index (AHI)

Time Frame: 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 Outcomes

  • Anthropometric measurements: tonsil size grading(up to 4 months)
  • Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position(up to 4 months)
  • Apnea/hypopnea index (AHI)(up to 4 months)
  • Anthropometric measurements: body mass index z-score (BMI z-score)(up to 4 months)
  • Snoring visual analogue scale (Snoring VAS)(up to 4 months)
  • Anthropometric measurements: uvular length(up to 4 months)

Study Sites (1)

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