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Clinical Predictors of Pediatric OSAHS (PEDOSA)

9 december 2015 bijgewerkt door: Chang Gung Memorial Hospital

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Slaapapneu bij kinderen

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Taiwan
- - Kaohsiung City, Taiwan, 833
    - Werving
    - Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
    - Contact:
      
      Hsin-Ching Lin, MD
      
      Telefoonnummer: 2533 886-7-7317123
      
      E-mail: enthclin@aol.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

children with chief complaints of snoring

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Clinical predictors for apnea/hypopnea index (AHI) Tijdsspanne: 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.	up to 4 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Anthropometric measurements: body mass index z-score (BMI z-score) Tijdsspanne: up to 4 months	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 Tijdsspanne: up to 4 months	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 Tijdsspanne: up to 4 months	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 Tijdsspanne: up to 4 months	uvular length in centimeter	up to 4 months
Snoring visual analogue scale (Snoring VAS) Tijdsspanne: up to 4 months	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) Tijdsspanne: up to 4 months	AHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.	up to 4 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chang Gung Memorial Hospital

Onderzoekers

Hoofdonderzoeker: Hsin-Ching Lin, MD, Department of Otolaryngology, Sleep Center, Kaohsiung Chang Gung Memorial Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2015

Primaire voltooiing (Werkelijk)

1 december 2015

Studie voltooiing (Verwacht)