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Clinical Predictors of Pediatric OSAHS (PEDOSA)

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ClinicalTrials.gov Identifier: NCT02627937
Recruitment Status : Unknown
Verified October 2015 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease
Pediatric Sleep Apnea

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Predictors of Pediatric Obstructive Sleep Apnea/Hypopnea Syndrome
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort
pediatric sleep apnea
The children were confirmed to have OSAHS by comprehensive polysomnography (PSG).


Outcome Measures
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Primary Outcome Measures :
  1. Clinical predictors for apnea/hypopnea index (AHI) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Anthropometric measurements: body mass index z-score (BMI z-score) [ Time Frame: 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.

  2. Anthropometric measurements: tonsil size grading [ Time Frame: 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.

  3. Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position [ Time Frame: 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.

  4. Anthropometric measurements: uvular length [ Time Frame: up to 4 months ]
    uvular length in centimeter

  5. Snoring visual analogue scale (Snoring VAS) [ Time Frame: up to 4 months ]
    Snoring VAS (Units on a Scale): 0-10, 0 = "no snoring noise" and 10 = "the loudest sound imaginable

  6. Apnea/hypopnea index (AHI) [ Time Frame: up to 4 months ]
    AHI: total number of apneas and hypopneas per hour of electroencephalographic sleep.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
children with chief complaints of snoring
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627937


Contacts
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Contact: Chi-Chih Lai, MD 886-7-7317123 ext 2533 gordon93@cgmh.org.tw

Locations
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Taiwan
Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung City, Taiwan, 833
Contact: Hsin-Ching Lin, MD    886-7-7317123 ext 2533    enthclin@aol.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Hsin-Ching Lin, MD Department of Otolaryngology, Sleep Center, Kaohsiung Chang Gung Memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02627937    
Other Study ID Numbers: CGMH IRB NO. 104-3716B
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: October 2015
Keywords provided by Chang Gung Memorial Hospital:
Pediatric obstructive sleep apnea/hypopnea syndrome
Polysomnography
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases