The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea.

BACKGROUND: Central sleep apnea (CSA), in association with obstructive disordered breathing, occurs in patients using opioids long-term and those with congestive heart failure. In these patients, treatment with CPAP frequently fails. The current adaptive servoventilation (ASV) devices are promising for the treatment of complex sleep-disordered breathing. These devices use algorithms to automatically titrate expiratory and inspiratory pressures. We hypothesized that an ASV device operating automatically would significantly reduce the frequency of breathing events in patients with mixed sleep apnea during polysomnography and with 3 months of treatment. METHODS: This was a prospective, multicenter, observational trial. Patients completed 3 nights of attended polysomnography, scored at an independent center. Twenty-seven patients with an apnea-hypopnea index (AHI) ≥ 15 and a central apnea index (CAI) ≥ 5/h underwent automated ASV titration without technician intervention. Twenty-six patients (96%) used ASV at home for 3 months. RESULTS: Patients had an AHI of 55 ± 24 (mean ± SD) and CAI of 23 ± 18 at baseline. Overnight, ASV titration improved AHI, CAI, obstructive apnea, and arousal index significantly. Patients reported better sleep quality on ASV than CPAP. Over 3 months, ASV remained effective (median AHI 11 vs four during polysomnography). Mean adherence was 4.2 h per night. Epworth Sleepiness Scale decreased from 12.8 to 7.8 (P = .001). CONCLUSIONS: The ASV device treated complex breathing disorders using automated algorithms. Compared with CPAP, patients reported improved sleep quality. Home use of ASV remained effective with acceptable adherence and improvements in daytime sleepiness. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01199042; URL: www.clinicaltrials.gov.

A randomized, double-blind, placebo-controlled study of an oral, extended-release formulation of phentermine/topiramate for the treatment of obstructive sleep apnea in obese adults.

STUDY OBJECTIVES: To evaluate safety and efficacy of phentermine 15 mg plus extended-release topiramate 92 mg for treatment of moderate to severe obstructive sleep apnea (OSA) in obese adults. DESIGN: This phase 2, randomized, double-blind, placebo-controlled study included 2-week screening and 28-week treatment periods. Overnight polysomnography was performed at baseline, Week 8, and Week 28. SETTING: Single-center study conducted from August 2008 to September 2009. PARTICIPANTS: Forty-five subjects with moderate to severe OSA not receiving positive airway pressure (PAP) treatment with body mass index of 30-40 kg/m(2). INTERVENTIONS: Subjects were randomized to receive placebo (n = 23) or phentermine 15 mg plus extended-release topiramate 92 mg (n = 22). Both groups received lifestyle-modification counseling. MEASUREMENTS AND RESULTS: Primary endpoint, change in apnea-hypopnea index (AHI), significantly favored phentermine 15 mg plus extended-release topiramate 92 mg (-31.5 events/h, 95% CI: -40.0, -22.9) over placebo (-16.6 events/h, 95% CI: -25.0, -8.2) at Week 28 (P =0.0084). At Week 28, there was a 10.2% (95% CI: -12.7, -7.6; 10.8 kg, 95% CI: -13.5, -8.0) mean decrease in weight in the phentermine 15 mg plus extended-release topiramate 92 mg group compared with 4.3% (95% CI: -6.6, -2.0; 4.7 kg, 95% CI: -7.2, -2.2) in the placebo group (P = 0.0006) and a positive, significant (P = 0.0003) correlation between percent change in weight and change in AHI. Significant improvements in overnight oxygen saturation and reduction in blood pressure compared with placebo were observed. Phentermine 15 mg plus extended-release topiramate 92 mg was well tolerated with low adverse event rates. CONCLUSIONS: Phentermine 15 mg plus extended-release topiramate 92 mg induced significant weight reductions and concomitant improvements in OSA and related symptoms vs placebo. This suggests weight loss mediated by phentermine 15 mg plus extended-release topiramate 92 mg may be useful in treatment of moderate to severe OSA in obese subjects unable or unwilling to comply with PAP treatment.