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High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

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Clalit Health Services

Status

Unknown

Conditions

Sleep Apnea, Obstructive

Treatments

Device: High flow nasal cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT03017859
RMC-16-0152

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

High flow nasal cannula treatment
Experimental group
Description:
Airvo 2 device will be used to administer high flow air during the night
Treatment:
Device: High flow nasal cannula

Trial contacts and locations

0

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Central trial contact

Avraham Unterman, MD

Data sourced from clinicaltrials.gov

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