High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

NCT ID: NCT03017859

Last Updated: 2017-01-11

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High flow nasal cannula treatment

Airvo 2 device will be used to administer high flow air during the night

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.

Interventions

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High flow nasal cannula

We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mordechai Kremer

Head of Pulmonary Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mordechai R Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Institute, Rabin Medical Center, Israel

Central Contacts

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Avraham Unterman, MD

Role: CONTACT

972-39377221

Other Identifiers

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RMC-16-0152

Identifier Type: -

Identifier Source: org_study_id

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