Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial.

BACKGROUND AND OBJECTIVE: Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm. METHODS: This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order. RESULTS: A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP. CONCLUSION: A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure. CLINICAL TRIAL REGISTRATION: NCT02683772 at clinicaltrials.gov.

Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial.

RATIONALE: Automated telemedicine interventions could potentially improve adherence to continuous positive airway pressure (CPAP) therapy. OBJECTIVES: Examining the effects of telemedicine-delivered obstructive sleep apnea (OSA) education and CPAP telemonitoring with automated patient feedback messaging on CPAP adherence. METHODS: This four-arm, randomized, factorial design clinical trial enrolled 1,455 patients (51.0% women; age, 49.1 ± 12.5 yr [mean ± SD]) referred for suspected OSA. Nine hundred and fifty-six underwent home sleep apnea testing, and 556 were prescribed CPAP. Two telemedicine interventions were implemented: 1) web-based OSA education (Tel-Ed) and 2) CPAP telemonitoring with automated patient feedback (Tel-TM). Patients were randomized to 1) usual care, 2) Tel-Ed added, 3) Tel-TM added, or 4) Tel-Ed and Tel-TM added (Tel-both). MEASUREMENTS AND MAIN RESULTS: The primary endpoint was 90-day CPAP usage. Secondary endpoints included attendance to OSA evaluation, and change in Epworth Sleepiness Scale score. CPAP average daily use at 90 days was 3.8 ± 2.5, 4.0 ± 2.4, 4.4 ± 2.2, and 4.8 ± 2.3 hours in usual care, Tel-Ed, Tel-TM, and Tel-both groups. Usage was significantly higher in the Tel-TM and Tel-both groups versus usual care (P = 0.0002 for both) but not for Tel-Ed (P = 0.10). Medicare adherence rates were 53.5, 61.0, 65.6, and 73.2% in usual care, Tel-Ed, Tel-TM, and Tel-both groups (Tel-both vs. usual care, P = 0.001; Tel-TM vs. usual care, P = 0.003; Tel-Ed vs. usual care, P = 0.07), respectively. Telemedicine education improved clinic attendance compared with no telemedicine education (show rate, 68.5 vs. 62.7%; P = 0.02). CONCLUSIONS: The use of CPAP telemonitoring with automated feedback messaging improved 90-day adherence in patients with OSA. Telemedicine-based education did not significantly improve CPAP adherence but did increase clinic attendance for OSA evaluation. Clinical trial registered with www.clinicaltrials.gov (NCT02279901).

Patient Engagement Using New Technology to Improve Adherence to Positive Airway Pressure Therapy: A Retrospective Analysis.

BACKGROUND: Sleep apnea has major neurocognitive and cardiovascular and metabolic risks. Treatment of sleep apnea is suboptimal because of variable adherence to existing therapies. METHODS: This trial compared positive airway pressure adherence among patients who were provided active patient engagement (APE) technology vs those who received usual care monitoring (UCM). The primary outcome was expressed by using the US Medicare definition of adherence. Adherence data from two cloud-based databases (AirView and myAir) were analyzed for patients with sleep apnea. Data were included if a patient's activation date in the APE tool was within 7 days of the therapy start date in the UCM database during a defined time window. Data were propensity matched in a 1:2 ratio (APE:UCM) based on baseline patient characteristics. RESULTS: A total of 128,037 patients were analyzed. Baseline characteristics were typical of a sleep clinic cohort. APE was associated with more patients achieving adherence criteria (87.3%) compared with UCM patients (70.4%; P < .0001 for the difference). Average therapy usage was 5.9 h per night in the APE group vs 4.9 h per night in the matched UCM patients (P < .0001). Patients with sleep apnea "struggling" with therapy adherence had a 17.6% absolute improvement in adherence using APE compared with UCM. CONCLUSIONS: Robust therapy adherence rates can be achieved by adding modern technology to usual care. Adopting advances in technology in care management may allow clinicians to more effectively and efficiently treat patients who have sleep apnea. Rigorous randomized controlled trials may be required before making strong clinical recommendations.