Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children.

Sleep Center, Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA.
Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine (Impact Factor: 2.93). 01/2012; 8(1):37-42. DOI: 10.5664/jcsm.1656
Source: PubMed

ABSTRACT To determine the effects of bilevel positive airway pressure with pressure release technology (Bi-Flex) on adherence and efficacy in children and adolescents compared to standard continuous positive airway pressure (CPAP) therapy. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.
This was a randomized, double-blinded clinical trial. Patients with obstructive sleep apnea were randomized to CPAP or Bi-Flex. Repeat polysomnography was performed on pressure at 3 months. Objective adherence data were obtained at 1 and 3 months.
56 children and adolescents were evaluated. There were no significant differences in the number of nights the device was turned on, or the mean number of minutes used at pressure per night for CPAP vs Bi-Flex (24 ± 6 vs 22 ± 9 nights, and 201 ± 135 vs 185 ± 165 min, respectively, for Month 1). The apnea hypopnea index decreased significantly from 22 ± 21/h to 2 ± 3/h on CPAP (p = 0.005), and 18 ± 15/h to 2 ± 2/h on Bi-Flex (p < 0.0005), but there was no significant difference between groups (p = 0.82 for CPAP vs Bi-Flex). The Epworth Sleepiness Scale decreased from 8 ± 5 to 6 ± 3 on CPAP (p = 0.14), and 10 ± 6 to 5 ± 5 on Bi-Flex (p < 0.0005; p = 0.12 for CPAP vs Bi-Flex).
Both CPAP and Bi-Flex are efficacious in treating children and adolescents with OSAS. However, adherence is suboptimal with both methods. Further research is required to determine ways to improve adherence in the pediatric population.

  • [Show abstract] [Hide abstract]
    ABSTRACT: Adherence to continuous positive airway pressure (CPAP) and noninvasive ventilation (NIV) is crucial for the successful treatment of sleep-disordered breathing. The aim of our study was to analyze the adherence of children to long-term home CPAP/NIV treatment. We analyzed data from all consecutive patients older than the age of 2years, in whom CPAP/NIV treatment was initiated in a specialized pediatric NIV and in those who were receiving CPAP/NIV treatment at home for at least 1month. Data of the memory cards of the ventilators and nocturnal gas exchange were analyzed during a routine CPAP/NIV overnight control in the hospital. CPAP/NIV adherence during the previous month was analyzed according to patient's age, ventilatory mode, type of interface, nocturnal gas exchange, and duration of treatment. The data of 62 children (mean age, 10±5years) with obstructive sleep apnea (n=51) treated with CPAP and neuromuscular disease (n=6) or lung diseases (n=5) treated with NIV were analyzed. Mean adherence was 8:17±2:30h:min per night, and the results did not significantly differ between CPAP and NIV adherence. Seventy-two percent of the patients used their device >8h per night. The mean number of nights of CPAP/NIV use during the last month was 26±5 nights per month. Treatment adherence was not correlated to age, the type of underlying disease, the type of interface (nasal, facial mask, or nasal cannula), nocturnal gas exchange, and duration of CPAP/NIV treatment. Long-term CPAP/NIV adherence at home was extremely high in this group of children followed in a pediatric NIV unit. This finding may explain the lack of effect of the interface, nocturnal gas exchange, and duration of CPAP/NIV treatment.
    Sleep Medicine 09/2013; · 3.49 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: OPINION STATEMENT: Dyssomnias are sleep disorders associated with complaints of insomnia or hypersomnia. The daytime sleepiness of narcolepsy is treated by a combination of planned daytime naps, regular exercise medications such as modafinil, or salts of methylphenidate, or amphetamine. Cataplexy that accompanies narcolepsy is treated with anticholinergic agents, selective serotonin reuptake inhibitors, or sodium oxybate. Children with neurodevelopmental disabilities such as autism have sleep initiation and maintenance difficulties on a multifactorial basis, with favorable response to melatonin in some patients. Childhood onset restless legs syndrome is often familial, associated with systemic iron deficiency, and responsive to iron supplementation and gabapentin. Parasomnias are episodic phenomena events which occur at the sleep -- wake transition or by intrusion on to sleep. Arousal parasomnias such as confusional arousals and sleep walking can sometimes be confused with seizures. A scheme for differentiating arousal parasomnias from nocturnal seizures is provided. Since arousal parasomnias are often triggered by sleep apnea, restless legs syndrome, or acid reflux, treatment measures directed specifically at these disorders often helps in resolution. Clonazepam provided in a low dose at bedtime can also alleviate sleep walking and confusional arousals. Obstructive sleep apnea affects about 2 percent of children. Adeno-tonsillar hypertrophy, cranio-facial anomalies, and obesity are common predisposing factors. Mild obstructive sleep apnea can be treated using a combination of nasal corticosteroids and a leukotriene antagonist. Moderate to severe obstructive sleep apnea are treated with adeno-tonsillectomy, positive airway pressure breathing devices, or weight reduction as indicated. This paper provides an overview of the topic, with an emphasis on management steps. Where possible, the level of evidence for treatment recommendations is indicated.
    Current Treatment Options in Neurology 09/2012; · 1.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The obstructive sleep apnea syndrome is common and its prevalence is expected to increase with the current obesity epidemic. If left untreated, it is associated with important morbidity such as growth failure, neurocognitive impairment, systemic and pulmonary hypertension, and endothelial dysfunction. Recent research has shown that many children, especially the obese or those with other underlying medical conditions, have residual obstructive sleep apnea after adenotonsillectomy (the primary treatment for childhood obstructive sleep apnea). These children could be effectively treated with continuous positive airway pressure but poor adherence is a significant limitation of this therapy. Therefore, new treatment modalities for the pediatric obstructive sleep apnea syndrome are needed. Current research has focused on newer therapies for pediatric obstructive sleep apnea, such as anti-inflammatories, dental treatments, high-flow nasal cannula, and weight loss. However, there are few randomized controlled trials assessing the effectiveness of these therapies. Further research is warranted.
    Paediatric Respiratory Reviews 09/2013; 14(3):199-203. · 2.77 Impact Factor

Full-text (2 Sources)

Available from
May 27, 2014