Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to
      oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are
      scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC
      procedure uses humidified room air delivered by nasal cannula at higher pressures and will
      test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the
      current clinical standard of care. All the infants in the study will have a brief test period
      of about 3 to 4 hours with the HFNC before participants begin their standard clinical PSG for
      titration of oxygen by nasal cannula for treatment of OSA.
    

Detailed description: 
      The current standard of care for treating OSA in infants less than 6 months and frequently up
      to 12 months of age is with a continuous flow of oxygen by nasal cannula. This is generally
      referred to as nasal continuous positive airway pressure or NCPAP. A nasal cannula is used
      with oxygen at low flows of between 1/4 to 1 liter per minute (l/m) to deliver supplemental
      oxygen to reduce oxygen desaturations associated with apneic episodes and to provide a
      positive pressure flow to maintain an open airway.

      High Flow Nasal Cannula (HFNC) therapy is a non-invasive treatment providing respiratory
      support. In this study, HFNC is designed to administer a heated and humidified mixture of air
      at a flow higher than the patient's inspiratory flow. There is currently no single, simple
      definition of high flow. In infants, it usually refers to a flow of >2 l/min and in children
      it is considered >6 l/min. High flow presents several advantages over conventional 'low-flow'
      oxygen therapy in terms of humidification, oxygenation, gas exchange, and breathing pattern.
      Several studies have shown that a flow higher than the patient's inspiratory flow provides
      better oxygen delivery than low-flow oxygen therapy or high-concentration oxygenation mask.
      This observation has been explained as the effect of a high flow on the oropharyngeal dead
      space, washing out oxygen depleted gas and reducing carbon dioxide (CO2) rebreathing. The
      extrathoracic dead space is proportionally two to three times greater in children than in
      adults. It may measure up to 3 mL/kg in newborns and becomes similar to the adult volume only
      after 6 years of age (0.8 mL/kg). Consequently, the younger a child is, the greater the
      effect of a high flow on oxygenation and CO2 clearance.

      This pilot study is to compare standard of care low flow nasal oxygen to the effectiveness of
      HFNC therapy in infants aged 12 months and younger to treat OSA. The study intervention will
      occur for approximately 3 to 4 hours immediately prior to a scheduled clinical PSG. Subjects
      will be prepared for standard clinical PSG and after asleep, the intervention will be
      titration of room air at different pressure flows delivered by a HFNC system. At the end of
      the research portion of the PSG, the clinical PSG will begin with the standard of care
      treatment, the nasal oxygen titration for OSA. The results of the clinical PSG will serve as
      control comparison for the research intervention.
    

Intervention name(s): HFNC; Low flow oxygen by nasal cannula
Intervention type(s): Other; Other
Intervention description(s): All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA; All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care) to manage sleep apnea
Other intervention name(s): High Flow Nasal Cannula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; obstructive sleep apnea; infants; high flow nasal cannula; HFNC