Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: CPAP; Device: HHHFNC

• Registration Number: NCT02515409
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-28
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-02
• Last Update Submitted: 2015-08-02
• Study First Posted: 2015-08-04
• Last Update Posted: 2015-08-04
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP	CPAP, as a first line treatment to OSAS.
HHHFNC	HHHFNC	Treatment with HHHFNC after CPAP treatment fails.

Primary Outcome Measures

Name	Time	Method
Average hours per night and per week using CPAP.	One year
Average hours per night and per week using HHHFNC .	One year

Secondary Outcome Measures

Name	Time	Method
Apnea hypopnea index (AHI)	One year	Severity of sleep apnea using AHI.
Pediatric sleep questionnaire (PSQ) score	One year	Obstructive sleep-related breathing disorders using PSQ score