Abstract
BACKGROUND: Obstructive sleep apnea is associated with high blood pressure. The magnitude of blood pressure effects from sleep apnea treatment is unclear. We aimed to determine the effect of mandibular advancement device therapy on ambulatory nighttime and daytime blood pressure in women and men with daytime sleepiness and snoring or mild to moderate sleep apnea (apnea-hypopnea index, <30). METHODS AND RESULTS: In this 4-month, double-blind, randomized controlled trial comprising 96 untreated patients, 27 women and 58 men, aged 31 to 70 years, completed the study. The active group received individually made adjustable mandibular advancement devices, and the control group was given individually made sham devices, to be used during sleep. Polysomnographic sleep recordings and ambulatory 24-hour blood pressure measurements were performed at baseline and at follow-up. In women with mandibular advancement devices, the mean nighttime systolic blood pressure was 10.8 mm Hg (95% confidence interval, 4.0-17.7 mm Hg; P=0.004) lower than in the women in the sham group, adjusted for baseline blood pressure, age, body mass index, and the apnea-hypopnea index. The mean nighttime adjusted diastolic blood pressure was 6.6 mm Hg (95% confidence interval, 2.7-10.4 mm Hg; P=0.002) lower in the mandibular advancement device group. In men, there were no significant differences in blood pressure at night or during the daytime between the intervention groups. CONCLUSIONS: A mandibular advancement device for obstructive sleep apnea reduces nocturnal blood pressure in women. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00477009.