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Clinical Predictors of Pediatric OSAHS (PEDOSA)

9 december 2015 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Pediatrisk sömnapné

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Taiwan
- - Kaohsiung City, Taiwan, 833
    - Rekrytering
    - Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
    - Kontakt:
      
      Hsin-Ching Lin, MD
      
      Telefonnummer: 2533 886-7-7317123
      
      E-post: enthclin@aol.com

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

children with chief complaints of snoring

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Clinical predictors for apnea/hypopnea index (AHI) Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chang Gung Memorial Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2015

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Förväntat)