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Nasal device (Provent) for the treatment of obstructive sleep apnea.
A Novel Nasal Expiratory Positive Pressure (EPAP) Device for the Treatment of Obstructive Sleep Apnea: a Randomized Controlled Trial.
Berry RB, Kryger MH, Massie CA
Journal of Clinical Sleep Medicine, 2011; 4: 479
Obstructive sleep apnea (OSA) is caused by the collapse of the throat (pharynx) during sleep. Continuous positive airway pressure (CPAP) treats OSA by blowing pressurized air into the throat, thus splinting it open. This study investigated a new device which works in a fashion somewhat similar to CPAP. Specifically, the device (Provent) is inserted into the nostrils and acts as a one-way valve that provides resistance on expiration (when a person breathes out) and, in doing so, creates back pressure which is transmitted to the throat and helps to keep it open during sleep. This randomized, controlled trial included 173 mainly male patients with documented OSA who were middle-aged (mean age 48 years), overweight (average body mass index of 33 kg/m2) but otherwise healthy. The patients were split into two groups: one was treated with Provent and the other was treated with a sham (placebo) device. At the beginning of the trial, all the patients underwent a diagnostic sleep study followed by a sleep study with either the Provent device or sham device in place. The patients then used the devices at home and, after 3 months, all the study participants underwent another 2 sleep studies, again with and without the devices in place. At baseline, the patients had moderate OSA with an average of 16.7 and 15.1 apneas and hypopneas per hour of sleep for the treatment and placebo groups, respectively. While the placebo group experienced no change in their apnea/hypopnea index (AHI), the Provent group experienced a reduction in their average AHI to 7.1 (normal AHI is < 5) during the first night of using the device. Similar changes in AHI were seen on the sleep studies performed 3 months later. Provent also modestly reduced daytime sleepiness compared to the placebo group as assessed by reductions in the Epworth Sleepiness Scale (ESS) score (from a baseline of 9.9 to 7.2 versus from 9.6 to 8.3 at 3 months, respectively). In general, ESS of 10 and above indicates excessive daytime sleepiness. Further, the study showed that Provent was well tolerated by the patients and it was used 88% of the nights for the duration of the study (3 months). The sham device was used 92% of the time during the 3 months. However, compliance data were based on patient self-report and was not validated objectively. In summary, this trial showed that, in a select population of patients with OSA, Provent reduced but did not completely normalize the AHI in association with a modest reduction in daytime sleepiness. However, many patients in this study did not, strictly speaking, suffer from excessive sleepiness, so it is difficult to interpret whether these findings are clinically significant for patients.
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