Prevalence of Childhood and Adult Obesity in the United States, 2011–2012

Abstract

O bstructive sleep apnea (OSA) is a common disorder that affects sleep and quality of life. Because many people with OSA cannot or will not comply with the standard treatment with a continuous positive airway pressure (CPAP) mask, alternative treatments have been sought. Upper-airway stimulation using unilateral stimulation of the hypoglossal nerve is a possible option. This multicenter, prospective, single-group, cohort trial and a follow-up randomized therapy-withdrawal trial were performed to evaluate the clinical safety and effectiveness of upper-airway stimulation for treating moderate to severe OSA.Patients who had difficulty accepting or adhering to CPAP treatment were included and served as their own controls. After initial screening, including polysomnography, qualified patients underwent surgery to implant the upper-airway stimulation system in which a stimulation electrode was placed on the hypoglossal nerve to recruit tongue-protrusion function. The sensing lead was placed between the internal and external intercostal muscles to detect ventilatory effort, and the neurostimulator was implanted in the right ipsilateral midinfraclavicular region. A month after implantation, patients had a second baseline diagnostic polysomnographic exam before the device was activated. Patients used a controller to initiate and stop therapy each night and then were assessed at 2, 3, 6, 9, and 12 months. The primary outcome was the change in the severity of OSA as determined by the apnea-hypopnea index (AHI; number of apnea or hypopnea events per hour; score ≥15 indicates moderate to severe OSA) and the O 2 desaturation index (ODI; number of times per hour of sleep that the blood O 2 level drops by ≥4 percentage points from baseline). At the 12-month assessment, a response to treatment was defined as an AHI reduction of 50% or greater from baseline and a score of less than 20 events per hour along with an ODI reduction of 25% or greater from baseline. The primary efficacy objectives were response rates of 50% or greater as assessed in the AHI and ODI. Secondary outcomes were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the O 2 saturation of less than 90%. Consecutive patients with a response were included in a randomized controlled therapywithdrawal trial in which they were assigned in a 1:1 ratio to either the therapy-maintenance or therapy-withdrawal group. The withdrawal group had the device turned off for 7 days; the maintenance group continued using the device. Polysomnography was done to measure the effects of withdrawal compared with continued use of therapy. Serious adverse events were those that led to death, lifethreatening illness, permanent impairment, or new or prolonged hospitalization with serious health impairment.Of the 126 participants, 83% were men; mean age was 54.5 years, and mean body mass index was 28.4 kg/m 2 . The mean AHI score on the initial screening polysomnography was 32.0 events per hour, and the mean ODI score was...

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