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

NCT ID: NCT02515409

Last Updated: 2015-08-04

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPAP

CPAP, as a first line treatment to OSAS.

CPAP

Intervention Type DEVICE

CPAP, as a first line treatment in OSAS.

HHHFNC

Treatment with HHHFNC after CPAP treatment fails.

HHHFNC

Intervention Type DEVICE

After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.

Interventions

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HHHFNC

After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.

Intervention Type DEVICE

CPAP

CPAP, as a first line treatment in OSAS.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 0-16 years old.
* Refered for treatment with non invasive ventilation.
* Diagnosed with OSAS and AHI\>=5
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keren Armoni-Domany, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Central Contacts

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Keren Armoni-Domany, Dr.

Role: CONTACT

+972-3-6974614

Other Identifiers

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TASMC-15-KA-0263-15-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id

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