Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this research study is to determine if auto-adjustable positive airway
      pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP
      is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to
      the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The
      difference is that APAP adjusts the pressure throughout the night with changes in resistance
      during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP
      is currently widely used to treat adults with OSA, however, this device has not yet been
      extensively studied in children.

      There are two parts to this research study. Subjects will begin using APAP at the time of
      enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP
      device over the 4-8 weeks with the pressure determined by a CPAP titration study. The
      titration study is a second overnight sleep study that is routinely ordered when a child with
      sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.

      In the second part of this study The investigators will compare the effects of APAP with CPAP
      to see what is reported as more comfortable and is used during more hours of sleep. This part
      of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks
      each.

      Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP
      until the results of the titration study are available. In this research, patients could be
      allowed to immediately start treatment with APAP. If APAP is found to be as safe and
      effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.
    

Detailed description: 
      This is a small clinical trial to test the feasibility of using APAP in children with sleep
      apnea.

      Continuous positive airway pressure (CPAP) is commonly used to treat OSA by delivering a
      predetermined amount of positive pressure to the patient's upper airway in order to reduce
      the collapsibility of airway structures during sleep. The commonly accepted method for
      determining the appropriate pressure setting for children with OSA is through an in-hospital
      overnight CPAP titration study. Another commonly used treatment modality in adults with OSA
      is auto-adjustable positive airway pressure (APAP), in which airway patency is maintained by
      adjusting pressure delivery through the night depending on the needs of the patient as
      determined by the device. Benefits of APAP compared with CPAP include the ability to initiate
      therapy without an inpatient CPAP titration study, resulting in more prompt establishment of
      treatment and cost-savings. Patient adherence may also be significantly improved as the
      pressure delivered is appropriate for sleep stage and patient position, resulting in greater
      patient comfort. Utility and efficacy of APAP compared to CPAP have never been evaluated in
      the pediatric population.

      The aim of this study is to establish APAP as an effective means of assessing CPAP pressure
      for OSA in children, and to determine if APAP therapy confers better treatment adherence and
      quality of life compared to traditional CPAP. The investigators hypothesize that APAP can
      effectively approximate the pressure determined by CPAP titration study, that APAP is
      superior to fixed CPAP in terms of treatment success, and that adherence to therapy will be
      improved with APAP compared to CPAP.

      Forty patients aged 5-20 years will be enrolled in the study. These subjects will be
      recruited from the pediatric pulmonary or pediatric sleep clinic at Cincinnati Children's
      Hospital. Patients who are suspected of having OSA will be referred in the usual manner to
      the sleep center for diagnostic sleep study (PSG). Following the establishment of OSA
      diagnosis and subsequent enrollment in the study, the subject will begin therapy with APAP
      which will continue for 4 to 8 weeks. In that period of time the clinically ordered
      in-hospital CPAP titration study will be completed. The subject will then be randomized to
      either traditional fixed pressure CPAP at the pressure determined by in-hospital titration or
      APAP. The subject will receive 4 weeks of treatment in the randomized group (CPAP or APAP)
      then crossover to 4 weeks in the alternate group (CPAP or APAP). Both patient and researcher
      will be blinded to the randomization of pressure modality. The total study period will range
      from 12-16 weeks.
    

Intervention name(s): crossover treatment (REMstar Auto A-Flex)
Intervention type(s): Device
Intervention description(s): All subjects will use same device with 4 week crossover of settings of APAP and CPAP
Other intervention name(s): REMstar Auto A-Flex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Pediatric Obstructive Sleep Apnea; Auto PAP; Auto-adjustable Positive Airway Pressure; APAP; CPAP