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

August 2, 2015 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Keren Armoni-Domany, Dr.
  • Phone Number: +972-3-6974614
  • Email: domany@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children ages 0-16 years with obstractive sleep apnea, referred for treatment with non invasive ventilation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CPAP
CPAP, as a first line treatment to OSAS.
Device: CPAP
CPAP, as a first line treatment in OSAS.
HHHFNC
Treatment with HHHFNC after CPAP treatment fails.
Device: HHHFNC
After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average hours per night and per week using HHHFNC .
Time Frame: One year
One year
Average hours per night and per week using CPAP.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea hypopnea index (AHI)
Time Frame: One year
Severity of sleep apnea using AHI.
One year
Pediatric sleep questionnaire (PSQ) score
Time Frame: One year
Obstructive sleep-related breathing disorders using PSQ score
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Keren Armoni-Domany, Dr., Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

August 2, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-15-KA-0263-15-TLV-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea, Obstructive

Clinical Trials on CPAP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe