Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome.

PURPOSE: Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS. METHODS: The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (≥ 50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (< 5/h, < 10/h, < 15/h). RESULTS: Overall treatment success rates were 89% in women and 76% in men (p = 0.019); corresponding rates in those with severe OSAS (AHI > 30/h) were 100% and 68% (p = 0.0015). In women vs. men, overall complete response rates at AHI cut-off values of < 5/h, <10/h, and < 15/h were 49 vs. 34% (p = 0.0052), 78 vs. 62% (p = 0.016), and 92 vs. 76% (p = 0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy. CONCLUSIONS: MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01326143).

Effect of switching from continuous to bilevel positive airway pressure on sleep quality in patients with obstructive sleep apnea: the prospective POP IN VAuto study.

Background: Issues with tolerability and side effects can decrease continuous positive airway pressure (CPAP) device usage and the benefits of therapy. Different positive airway pressure (PAP) therapy modes providing expiratory pressure relief or using a different pressure during inspiration vs. expiration (bilevel PAP) may alleviate some of these issues. This multicenter, prospective study evaluated the effects of switching from CPAP to bilevel PAP (VAuto mode) on respiratory parameters, device usage, side effects and patient-reported outcomes in patients with obstructive sleep apnea (OSA). Methods: Eligible OSA patients had started CPAP ≥3 months previously, had good compliance (mean 6.1±2.0 h/night) and well-controlled OSA [residual apnea-hypopnea index (AHI) 4.9±3.1/h] but had pressure tolerance issues or persistent side effects/discomfort. All were switched from CPAP to bilevel PAP (AirCurve 10 VAuto; ResMed). Effectiveness (residual AHI), sleep quality, daytime sleepiness, fatigue, therapy-related side effects, and patient satisfaction/preference were assessed after 3 months and 1 year. Results: Forty patients were analyzed (68% male, age 64±11 years, body mass index 30.7±5.8 kg/m2). At 3 months and 1 year after switching to bilevel PAP, median [interquartile range] residual AHI was 4/h [2-5.3] and 3.7/h [1.8-5], respectively, and device usage was 7.0 [4.9-7.5] and 6.4 [4.4-7.3] h/night, respectively. Device switch was associated with significant reductions from baseline in expiratory PAP {from 12 [11-13] to 8 [7-9] cmH2O at 3 months (P<0.001) and 9 [8-12] cmH2O at 1 year (P=0.005)}, 95th percentile pressure {from 14 [12-14] to 10 [9-11] and 10 [8-11] cmH2O; P<0.001 and P=0.001, respectively} and leak {from 1 [0-6] to 0 [0-1] and 0 [0-2] L/min; P=0.049 and P=0.033, respectively}. The Pittsburgh Sleep Quality Index score decreased significantly from baseline to 3 and 6 months [7.2±4.0 to 5.0±3.2 (P=0.005) and 4.5±2.7 (P<0.001), respectively]. CPAP-related mouth dryness, choking sensation and aerophagia were significantly improved one year after switching to bilevel PAP. Bilevel PAP was preferred over CPAP by 90% of patients. Conclusions: Switching to bilevel PAP had several benefits in patients struggling with CPAP, facilitating therapy acceptance and ongoing device usage.

CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. DESIGN: A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. SETTING: Sleep clinics in France. PATIENTS OR PARTICIPANTS: 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). INTERVENTIONS: Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. MEASUREMENTS: The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. RESULTS: Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. CONCLUSIONS: CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT01226641.

Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea.

INTRODUCTION: Obstructive sleep apnea (OSA) is associated with cardiovascular morbidity, including hypertension. Beyond the severity of nocturnal hypoxia, other factors such as metabolic abnormalities but also sedentary behaviors and insufficient physical activity may contribute to elevated blood pressure (BP). To clarify the respective role of these factors as determinants of BP in OSA patients, we examined the relationship between BP and anthropometrics, severity of sleep apnea, and objectively measured physical activity and sedentary behaviors. METHODS: Ninety-five adults presenting with OSA (apnea-hypopnea index > 10 events/h) and high cardiovascular risk (63.3 ± 8.8 y; body mass index: 29.9 ± 4.9 kg/m(2); apnea-hypopnea index: 41.3 ± 17.5/h; cardiovascular risk score: 13.5 ± 3.7%) were included. Physical activity and sedentary behaviors were objectively assessed by actigraphy, and self-measured home BP monitoring was measured. Logistic regression models adjusted for sex, age, and body mass index were built to identify the predictors of self-measured morning and evening BP. RESULTS: Physical activity was significantly related to obesity but not to the severity of sleep apnea or sleepiness. Sedentary behaviors were associated with self-measured morning and evening systolic BP (r = 0.32, P = .002; r = 0.29, P = .004). Steps per day were inversely associated with evening BP (r = -0.27, P = .01). Univariate analysis identified steps/d and time spent in vigorous physical activity as determinants for evening self-measured BP. In multivariate analysis, only steps/d were identified as a significant determinant of evening BP. CONCLUSIONS: Physical activity is the major determinant for evening BP in adults with OSA presenting high cardiovascular risk. Our results emphasize the need for lifestyle counseling programs in combination with CPAP to encourage regular physical activity in OSA subjects to obtain better BP control. (ClinicalTrials.gov registration NCT01226641.)