Clinical Predictors of Pediatric OSAHS (PEDOSA)

Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Pediatric Sleep Apnea

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.

• Study Type: Observational
• Enrollment (Anticipated): 88

Contacts and Locations

• Study Contact: Name: Chi-Chih Lai, MD; Phone Number: 2533 886-7-7317123; Email: gordon93@cgmh.org.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
    • Contact: Hsin-Ching Lin, MD; Phone Number: 2533 886-7-7317123; Email: enthclin@aol.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children with chief complaints of snoring

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pediatric sleep apnea; The children were confirmed to have OSAHS by comprehensive polysomnography (PSG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Anthropometric measurements: uvular length	uvular length in centimeter	up to 4 months
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
Apnea/hypopnea index (AHI)	AHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.	up to 4 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Hsin-Ching Lin, MD, Department of Otolaryngology, Sleep Center, Kaohsiung Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Polysomnography; Pediatric obstructive sleep apnea/hypopnea syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: CGMH IRB NO. 104-3716B