High Flow Nasal Cannula as a Treatment for Obstructive Sl... | NCT03017859

Studies
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

NCT03017859

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jan 11, 2017Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Sleep Apnea, Obstructive

Interventions

High flow nasal cannula

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

Jan 2017

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

Jan 2017

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jan 9, 2017

First Submission Date that Met QC Criteria

Jan 9, 2017

First Posted Date

Jan 11, 2017Estimated

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

Jan 9, 2017

Last Update Posted Date

Jan 11, 2017Estimated

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

A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.

Detailed Description

A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High flow nasal cannula treatment	Experimental	Airvo 2 device will be used to administer high flow air during the night	Device: High flow nasal cannula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High flow nasal cannula	Device	We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.	High flow nasal cannula treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apnea Hypopnea Index (AHI)	Comparison of HFNC AHI to baseline AHI and to CPAP AHI	During at least 2 hours of sleep time

Secondary Outcomes

Measure	Description	Time Frame
Percent of hypoxemia time	O2 saturation (SO2)<90% as measured by pulse oximeter	During at least 2 hours of sleep time
Minimal SO2%		During at least 2 hours of sleep time

Other Outcomes

Measure	Description	Time Frame
Percent rapid eye movement (REM) sleep		During at least 2 hours of sleep time
Percent Deep sleep		During at least 2 hours of sleep time
User experience with HFNC

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80 years
Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
Apnea Hypopnea Index (AHI)≥15
Patient has difficulties to adjust or comply with CPAP treatment
Signed Informed Consent Form

Exclusion Criteria:

Patients who need bilevel positive airway pressure (BIPAP)
Known carbon dioxide (CO2) retainers
Weight change>10% compared to time of OSA diagnosis
Clinically unstable patients
Pregnant women or special populations (e.g. children or patients unable to give informed consent)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Avraham Unterman, MD	Contact	972-39377221		ramiun@clalit.org.il

Overall Officials

Name	Affiliation	Role
Mordechai R Kramer, MD	Pulmonary Institute, Rabin Medical Center, Israel	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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

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Browse Branches

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