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Clinical Predictors of Pediatric OSAHS

NCT ID: NCT02627937

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Pediatric Sleep Apnea

Keywords

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Pediatric obstructive sleep apnea/hypopnea syndrome Polysomnography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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pediatric sleep apnea

The children were confirmed to have OSAHS by comprehensive polysomnography (PSG).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsin-Ching Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Sleep Center, Kaohsiung Chang Gung Memorial Hospital

Locations

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Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chi-Chih Lai, MD

Role: CONTACT

Phone: 886-7-7317123

Email: [email protected]

Facility Contacts

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Hsin-Ching Lin, MD

Role: primary

Other Identifiers

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CGMH IRB NO. 104-3716B

Identifier Type: -

Identifier Source: org_study_id