Clinical Predictors of Pediatric OSAHS

NCT02627937 | Unknown DMC

• 1 other identifier: CGMH IRB NO. 104-3716B
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Sleep Apnea

Keywords

Pediatric obstructive sleep apnea/hypopnea syndrome; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Clinical predictors for apnea/hypopnea index (AHI)

  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

Secondary Outcomes (6)

• Anthropometric measurements: body mass index z-score (BMI z-score)

  up to 4 months

• Anthropometric measurements: tonsil size grading

  up to 4 months

• Anthropometric measurements: modified Mallampati grade (aka updated Friedman's tongue position

  up to 4 months

• Anthropometric measurements: uvular length

  up to 4 months

• Snoring visual analogue scale (Snoring VAS)

  up to 4 months

Study Arms (1)

pediatric sleep apnea

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

children with chief complaints of snoring

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Otolaryngology, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 833, Taiwan

RECRUITING

Study Officials

• Hsin-Ching Lin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Chih Lai, MD

CONTACT

886-7-7317123; gordon93@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-10

Locations

TW (1)