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Clinical Predictors of Pediatric OSAHS

Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02627937
Acronym
PEDOSA
Enrollment
88
Registered
2015-12-11
Start date
2015-06-30
Completion date
2015-12-31
Last updated
2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Sleep Apnea

Keywords

Pediatric obstructive sleep apnea/hypopnea syndrome, Polysomnography

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical predictors for apnea/hypopnea index (AHI)up to 4 monthsWhen 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

MeasureTime frameDescription
Anthropometric measurements: tonsil size gradingup to 4 monthsTonsil 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 positionup to 4 monthsupdated 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.
Anthropometric measurements: body mass index z-score (BMI z-score)up to 4 monthsBMI 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 monthsSnoring VAS (Units on a Scale): 0-10, 0 = no snoring noise and 10 = the loudest sound imaginable
Apnea/hypopnea index (AHI)up to 4 monthsAHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.
Anthropometric measurements: uvular lengthup to 4 monthsuvular length in centimeter

Countries

Taiwan

Contacts

Primary ContactChi-Chih Lai, MD
gordon93@cgmh.org.tw886-7-7317123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026