Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Auto-adjustable Positive Airway Pressure (APAP) in Pediatric Patients With Obstructive Sleep Apnea (OSA).

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: crossover treatment (REMstar Auto A-Flex)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5 to 20 years of age apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation Exclusion Criteria: significant cranio-facial abnormalities chromosomal abnormalities that would affect compliance cerebral palsy significant neurological disease or neuromuscular disease

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 crossover treatment<br>crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks APAP settings then 4 weeks CPAP settings. | Device: crossover treatment (REMstar Auto A-Flex)<br>* All subjects will use same device with 4 week crossover of settings of APAP and CPAP<br>* Other names: REMstar Auto A-Flex;|
| Active Comparator: Group 2 crossover treatment<br>crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks CPAP settings then 4 weeks APAP settings. | Device: crossover treatment (REMstar Auto A-Flex)<br>* All subjects will use same device with 4 week crossover of settings of APAP and CPAP<br>* Other names: REMstar Auto A-Flex;|
| Active Comparator: APAP pressurized comparison<br>randomization periods for 6-8 weeks. An in-hospital APAP titration study will average 90th pressure percentile and average CPAP pressure derived from the device will be compared to the CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group. | Device: crossover treatment (REMstar Auto A-Flex)<br>* All subjects will use same device with 4 week crossover of settings of APAP and CPAP<br>* Other names: REMstar Auto A-Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study | The aim of this study is to establish APAP as an effective treatment modality for OSAS in the pediatric population. We hypothesize that APAP can effectively approximate the pressure determined by PSG CPAP titration as measured by the average 90th pressure percentile and average CPAP pressure delivered to the patient. The in-lab CPAP titration PSG following initial diagnosis of OSA is the current standard of therapy. APAP would potentially bridge the gap between the time of diagnosis and the follow up PSG for CPAP titration, allowing for more prompt intervention. | First visit after APAP run-in at 6-8 weeks | 
| Adherence Comparison of APAP vs.CPAP (% Days Device Used and % Days Device Used >4 Hours) | Randomized crossover period comparison of adherence between APAP and CPAP calculated from therapy usage hours. | end of study visit at 12-16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michigan Pediatric Sleep Questionnaire | Comparison of Michigan pediatric sleep questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale range is from 0 to 1, Normal <0.33, at risk is 0.33-0.55 and >0.55 abnormal. | 12-16 weeks | 
| Epworth Sleepiness Scale Questionnaire | Comparison of Epworth Sleepiness scale questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale range is from 0 to 24, with a value of 10 or greater suggesting significance for sleep disordered breathing. | 12-16 weeks | 
| Comparison of Pediatric Quality of Life Inventory Questionnaire Score Between Baseline and Each Randomization Period | Comparison of Pediatric Quality of Life Inventory questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale scores range between 0-100. Higher scores indicate better health related quality of life. Healthy: 81.34-100, at risk: 81.33-65.4, unhealthy <65.4 | 12-16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, Auto PAP, Auto-adjustable Positive Airway Pressure, APAP, CPAP