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High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03017859
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: High flow nasal cannula Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Study Start Date : January 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: High flow nasal cannula treatment
Airvo 2 device will be used to administer high flow air during the night
Device: High flow nasal cannula
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.




Primary Outcome Measures :
  1. Apnea Hypopnea Index (AHI) [ Time Frame: During at least 2 hours of sleep time ]
    Comparison of HFNC AHI to baseline AHI and to CPAP AHI


Secondary Outcome Measures :
  1. Percent of hypoxemia time [ Time Frame: During at least 2 hours of sleep time ]
    O2 saturation (SO2)<90% as measured by pulse oximeter

  2. Minimal SO2% [ Time Frame: During at least 2 hours of sleep time ]
  3. Adverse events reported while using HFNC [ Time Frame: During at least 2 hours of sleep time ]
  4. Sleep efficiency [ Time Frame: During at least 2 hours of sleep time ]
  5. Total sleep time [ Time Frame: During at least 2 hours of sleep time ]

Other Outcome Measures:
  1. Percent rapid eye movement (REM) sleep [ Time Frame: During at least 2 hours of sleep time ]
  2. Percent Deep sleep [ Time Frame: During at least 2 hours of sleep time ]
  3. User experience with HFNC [ Time Frame: During at least 2 hours of sleep time ]
    To be assessed in the following morning with questionnaires



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017859


Contacts
Contact: Avraham Unterman, MD 972-39377221 ramiun@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, MD Pulmonary Institute, Rabin Medical Center, Israel

Responsible Party: Mordechai Kremer, Head of Pulmonary Institute, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03017859     History of Changes
Other Study ID Numbers: RMC-16-0152
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases