None listed
Conditions
Brief summary
This trial compared two breathing therapies — high-flow nasal cannula (HFNC) and CPAP (the current standard treatment), to see whether HFNC was effective as well, and also tolerated for children with moderate-to-severe obstructive sleep apnoea. We also asked children which one they found more comfortable. Each child was studied for one night while sleeping, using sensors to measure how well they were breathing and sleeping on each therapy.
Interventions
The primary objective of this study is to compare the effectiveness of high flow nasal cannula (HFNC) therapy to gold standard continuous pressure airway pressure (CPAP) therapy in improving polysomnography (PSG) parameters of children with moderate or severe obstructive sleep apnoea (OSA) during a single night study. The secondary objective of the study is to compare patient tolerance and comfort of HFNC therapy to CPAP therapy. Children initially underwent a standard diagnostic overnight PSG. Those diagnosed with moderate-to-severe OSA who were not considered suitable candidates for therapeutic surgical intervention, such as adenotonsillectomy, were routinely referred for CPAP therapy as part of standard clinical care. These children would ordinarily return to the sleep laboratory for an overnight CPAP titration study. Participants who consented to the study were offered an additional overnight heated humidified HFNC titration study prior to their scheduled CPAP titration. HFNC was performed first, followed by the clinically indicated CPAP titration within four weeks. This additional study did not delay or alter routine clinical care, as CPAP titration is typically scheduled two to four weeks following diagnostic PSG because of patient scheduling and sleep laboratory availability. HFNC was delivered using the Fisher & Paykel AIRVO™ 2 system with warmed, humidified room air administered via appropriately sized nasal cannulae. Nasal prongs were selected to occupy approximately 50% of each nare. Initial flow rates were determined according to participant weight and titrated throughout the overnight study by an experienced sleep clinical nurse technologist to minimise obstructive respiratory events while maintaining participant comfort. Children weighing less than 10 kg commenced at 1 L/kg/min, with flow increased in 1 L/min increments to a maximum of 2 L/kg/min. Participants weighing 10 kg or more commenced at 10 L/min, with flow increased in 5 L/min increments to a maximum of 2 L/kg/min or 60 L/min, whichever was lower. CPAP titration was subsequently performed during a separate overnight attended PSG according to standard departmental protocols. Therapy was initiated at 4 cmH2O and increased in 1 cmH2O increments until obstructive respiratory events were adequately controlled or the maximum therapeutic pressure was reached. All intervention procedures were undertaken with close clinical supervision at all times within the sleep lab. All PSG studies were scored according to American Academy of Sleep Medicine paediatric scoring criteria and interpreted independently by sleep physicians blinded to the results of the alternate treatment study. Participant- or parent-reported comfort questionnaires were completed following each intervention to assess treatment tolerability and preference.
Sponsors
Study design
Eligibility
Inclusion criteria
All children under 16 years of age with baseline PSG diagnosed moderate or severe OSA in whom a CPAP trial is planned by a sleep physician. Informed consent in accordance with the institutional policies must be signed by the patient's legally authorised guardian acknowledging written consent to join the study.
Exclusion criteria
-Children with a current upper respiratory tract infection -Children who are receiving oxygen therapy -Children with OSA and co-existing central sleep apnoea with a central apnoea/hypopnea index > 5 events per hour.