Heated Humidified High Flow Nasal Cannula for Children Wi... | NCT02515409

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

NCT02515409

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Aug 4, 2015Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Sleep Apnea, Obstructive

Interventions

HHHFNC
CPAP

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Jun 28, 2015

First Submission Date that Met QC Criteria

Aug 2, 2015

First Posted Date

Aug 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2015

Last Update Posted Date

Aug 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP		CPAP, as a first line treatment to OSAS.	Device: CPAP
HHHFNC		Treatment with HHHFNC after CPAP treatment fails.	Device: HHHFNC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HHHFNC	Device	After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.	HHHFNC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keren Armoni-Domany, Dr.	Contact	+972-3-6974614		domany@gmail.com

Overall Officials

Name	Affiliation	Role
Keren Armoni-Domany, Dr.	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided