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NCT02515409 Clinical Trial

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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02515409
Other study ID # TASMC-15-KA-0263-15-TLV-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 28, 2015
Last updated August 2, 2015
Start date August 2015
Est. completion date August 2017

Study information
Verified date June 2015
Source Tel-Aviv Sourasky Medical Center
Contact Keren Armoni-Domany, Dr.
Phone +972-3-6974614
Email domany@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion criterias:

- Age: 0-16 years old.

- Refered for treatment with non invasive ventilation.

- Diagnosed with OSAS and AHI>=5

There are no exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• HHHFNC
After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.
• CPAP
CPAP, as a first line treatment in OSAS.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Average hours per night and per week using HHHFNC . One year No
Primary Average hours per night and per week using CPAP. One year No
Secondary Apnea hypopnea index (AHI) Severity of sleep apnea using AHI. One year No
Secondary Pediatric sleep questionnaire (PSQ) score Obstructive sleep-related breathing disorders using PSQ score One year No
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