Clinical trial NCT02627937: Clinical Predictors of Pediatric OSAHS
Official title: Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Sleep Apnea
Keywords: Pediatric obstructive sleep apnea/hypopnea syndrome
Polysomnography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with chief complaints of snoring

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.

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.

Primary outcomes:
measure: Clinical predictors for apnea/hypopnea index (AHI)
timeFrame: up to 4 months
Secondary outcomes:
measure: Anthropometric measurements: body mass index z-score (BMI z-score)
timeFrame: up to 4 months
measure: Anthropometric measurements: tonsil size grading
timeFrame: up to 4 months
measure: Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position
timeFrame: up to 4 months
measure: Anthropometric measurements: uvular length
timeFrame: up to 4 months
measure: Snoring visual analogue scale (Snoring VAS)
timeFrame: up to 4 months
measure: Apnea/hypopnea index (AHI)
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Otolaryngology, Sleep Center, Kaohsiung Chang Gung Memorial Hospital
name: Hsin-Ching Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: