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Clinical Predictors of Pediatric OSAHS (PEDOSA)

9. december 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

88

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Rekruttering
        • Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

children with chief complaints of snoring

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical predictors for apnea/hypopnea index (AHI)
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chang Gung Memorial Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Forventet)

1. december 2015

Datoer for studieregistrering

Først indsendt

6. november 2015

Først indsendt, der opfyldte QC-kriterier

9. december 2015

Først opslået (Skøn)

11. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. december 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CGMH IRB NO. 104-3716B

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

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