Goal 2: Reduce Human Disease

Risk factors for sleep-disordered breathing in patients with COPD

What are the risk factors for sleep-disordered breathing in patients with COPD (the “overlap syndrome")?

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Clinical Trials in Pediatric Sleep Disorders - Effect of adenotonsillectomy

Effect of adenotonsillectomy on behavioral and cardiovascular outcomes in children with primary snoring

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The recent NHLBI Childhood Adenotonsillectomy (CHAT) study showed highly significant behavioral improvements in children with obstructive sleep apnea syndrome . This study included children with an apnea hypopnea index as low as 2/hr. Many small or suboptimally controlled studies suggest that even primary snoring can affect behavior. If large randomized controlled trials confirm this finding, it will radically affect the treatment of the estimated 10% of children who snore.

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Goal 2: Reduce Human Disease

Clinical Trials in Pediatric Sleep Disorders - Effect of adenotonsillectomy

Effect of adenotonsillectomy on neurocognitive and behavioral outcomes in infants and and toddlers with obstructive sleep apnea syndrome.

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The CHAT study showed few significant changes in cognitive outcomes in school-aged children with OSAS. However, these children (aged 5-9 years) may have suffered from OSAS too long to allow for reversibility of central nervous system damage. The peak prevalence of OSAS occurs in much younger children. Theoretically, these children are much more likely to show cognitive improvement after treatment, due to a shorter duration of OSAS (with its resultant hypoxemic damage) and increased plasticity of their nervous system. These young children are often not treated, due to either underdiagnosis or concern about the increased risks of adenotonsillectomy in very young children. Thus, if it is found that early treatment reverses cognitive damage, the clinical management of these children would be profoundly affected.

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Clinical Trials in Pediatric Sleep Disorders

Effectiveness of medications for cataplexy in children.

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Pediatric sleep experts agree that there appears to be a mini-epidemic of narcolepsy in children currently, characterized by acute onset of disease with severe symptoms and difficult to control cataplexy, in very young children. No drugs are approved for treatment of cataplexy in children, and drugs typically used in adults are not FDA-approved for use in children. A multicenter trial would be needed in order to accumulate sufficient cases for a randomized controlled trial.

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Goal 2: Reduce Human Disease

Sleep Apnea

Does treatment of sleep apnea prevent cardiovascular disease?

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Clinical Trials in Pediatric Sleep Disorders

Effect of anti-inflammatory medications (including nasal steroids and leukotriene antagonists) in children with obstructive sleep apnea syndrome, stratified for severity of OSAS as well as presence of atopy.

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Small studies suggest a therapeutic effect of anti-inflammatory medication in childhood OSAS. This may be especially useful in children with residual OSAS following adenotonsillectomy (as CPAP adherence tends to be low) or children who are poor candidates for surgery. Current studies have been limited to children with extremely mild OSAS, have not determined whether atopy plays a role in the response to therapy, and have been limited to very short-term trials.

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Clinical Trials in Pediatric Sleep Disorders

Long-term risk of recurrence of obstructive sleep apnea in children successfully treated with surgery during childhood.

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Very small, incomplete, retrospective studies, and some new emerging data from Hong Kong, suggest that a significant number of children with obstructive sleep apnea syndrome will develop progressive symptoms later in life, or will develop recurrence of OSAS after adenotonsillectomy. Further studies are needed to determine the long-term risk of recurrence. Results of this trial will influence clinical management in regards to ongoing surveillance and secondary prevention techniques.

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Sleep Apnea

Does alteration of sleep duration improve patient outcomes in sleep apnea?

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Sleep Apnea

Does treating sleep apnea benefit patients with obstructive lung disease?

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Goal 2: Reduce Human Disease

Sleep Apnea

The general area is that of preoperative risk management of sleep apnea patients undergoing major surgery. This field is burgeoning with clinical activity. A large amount of healthcare dollars are expended annually in order to detect sleep apnea and offer therapy that is of unproven value. Most all of the data is retrospective case series or a mixture of retrospective and prospective cohort studies. Yet, across the country, ...more »

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The existing data shows that sleep apnea may be moderate risk factor for poor outcomes and complications from surgery but the magnitude of the risk and the degree to which sleep apnea therapy modifies this risk is not known and won’t be determined without larger scale trials. This field desperately needs some randomized trials to answer some of these questions. Trials which randomize patients undergoing some major surgery to a sleep apnea treatment with CPAP if OSA is diagnosed before surgery  vs. treating with CPAP after surgery in the post operative period is one such study that could be performed.

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