Sleep
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized, double-blind clinical trial comparing continuous positive airway pressure with a novel bilevel pressure system for treatment of obstructive sleep apnea syndrome.
To obtain efficacy, objective compliance, and self-assessment data from obstructive sleep apnea syndrome (OSAS) patients treated with continuous positive airway pressure (CPAP) or a novel bilevel (NBL) therapy. ⋯ The NBL appeared to be as effective as CPAP for the treatment of OSAS but offered no advantages in patients receiving first-time therapy for OSAS.
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Randomized Controlled Trial Clinical Trial
A randomized crossover efficacy trial of oral CPAP (Oracle) compared with nasal CPAP in the management of obstructive sleep apnea.
To determine the therapeutic efficacy and viability of a novel oral interface for continuous positive airway pressure (CPAP) compared with conventional nasal interfaces. ⋯ This preliminary study indicates that oral CPAP has similar efficacy to traditionally applied nasal CPAP in treating obstructive sleep apnea. Additional large studies are required to determine the range of clinical situations where oral CPAP is indicated.
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Randomized Controlled Trial Clinical Trial
The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation.
To inform the debate over whether human sleep can be chronically reduced without consequences, we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation. ⋯ Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation, it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults. Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits, which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign. Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses, but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions. This suggests that sleep debt is perhaps best understood as resulting in additional wakefulness that has a neurobiological "cost" which accumulates over time.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy.
To evaluate the long-term safety and efficacy of nightly sodium oxybate for the treatment of narcolepsy. ⋯ Sodium oxybate is an effective and well-tolerated treatment for narcolepsy.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy.
To evaluate and compare the efficacy and safety of three doses of sodium oxybate and placebo for the treatment of narcolepsy symptoms. ⋯ Sodium oxybate significantly improved symptoms in patients with narcolepsy and was well tolerated.