NCT02515409

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

June 28, 2015

Last Update Submit

August 2, 2015

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea Syndrome (OSAS)Heated Humidified High Flow Nasal Cannula (HHHNC)Continues positive airway pressure (CPAP)ChildrenNon invasive ventilationTreatment

Outcome Measures

Primary Outcomes (2)

  • Average hours per night and per week using HHHFNC .

    One year

  • Average hours per night and per week using CPAP.

    One year

Secondary Outcomes (2)

  • Apnea hypopnea index (AHI)

    One year

  • Pediatric sleep questionnaire (PSQ) score

    One year

Study Arms (2)

CPAP

CPAP, as a first line treatment to OSAS.

Device: CPAP

HHHFNC

Treatment with HHHFNC after CPAP treatment fails.

Device: HHHFNC

Interventions

HHHFNCDEVICE

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

HHHFNC
CPAPDEVICE

CPAP, as a first line treatment in OSAS.

CPAP

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Keren Armoni-Domany, Dr.

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keren Armoni-Domany, Dr.

CONTACT

+972-3-6974614domany@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2015

First Posted

August 4, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 4, 2015

Record last verified: 2015-06