Clinical Predictors of Pediatric OSAHS

Pediatric Sleep Apnea Clinical Trial

— PEDOSA  

Official title:

Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627937
• Other study ID #: CGMH IRB NO. 104-3716B
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2015
• Last updated: December 9, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Chang Gung Memorial Hospital
• Contact: Chi-Chih Lai, MD
• Phone: 886-7-7317123
• Email: gordon93[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pediatric Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Taiwan	Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical predictors for apnea/hypopnea index (AHI)	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.	up to 4 months	No
Secondary	Anthropometric measurements: body mass index z-score (BMI z-score)	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.	up to 4 months	No
Secondary	Anthropometric measurements: tonsil size grading	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.	up to 4 months	No
Secondary	Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position	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.	up to 4 months	No
Secondary	Anthropometric measurements: uvular length	uvular length in centimeter	up to 4 months	No
Secondary	Snoring visual analogue scale (Snoring VAS)	Snoring VAS (Units on a Scale): 0-10, 0 = "no snoring noise" and 10 = "the loudest sound imaginable	up to 4 months	No
Secondary	Apnea/hypopnea index (AHI)	AHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.	up to 4 months	No