Based on patient choice, 72 patients preferred to receive a 12-month nCPAP treatment with an auto-titrating device (pressure: 4–12 cm H2O, AirSense 10 AutoSet, ResMed, Ltd., Bella Vista, Australia). Patients were encouraged to use a nasal mask (MirageFX, ResMed, Ltd.) and a heated humidification system (HumidAir, ResMed, Ltd.). The auto-pressure modus was used during the entire study period. After initiation of nCPAP therapy by a trained study nurse, further support was provided by a web-based telemedicine system (AirView, ResMed, Ltd.). The telemedicine data were screened by a specially trained study nurse, who examined adherence, mask leakage, and residual apneas each week, and established telephone contact if necessary. The first follow-up study visit was scheduled for 3 months after initiation of nCPAP treatment. Continued intervention was defined as use of nCPAP for 4 hours per night during 70% of the recorded nights.[15 (link)] Ultimately, 52 patients (mild OSA: n = 32; moderate/severe OSA: n = 20) completed the 12-month nCPAP treatment, and 20 OSA patients were excluded because of loss to follow-up, discontinued intervention, missing data, or malignancy.
Airsense 10 autoset
Manufactured by Resmed
Sourced in Australia, France
The AirSense 10 AutoSet is a continuous positive airway pressure (CPAP) device designed to treat sleep apnea. It automatically adjusts air pressure to the user's breathing needs throughout the night.
Automatically generated - may contain errors
6 protocols using airsense 10 autoset
1
12-Month Autotitrating CPAP Treatment for OSA
2
APAP Adherence and Residual Respiratory Events
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All participants used a ResMed AirSense 10 AutoSet machine with the ability to automatically upload adherence data to ResMed AirViewTM (cloud-based system) or from an SD card for review. The patient’s machine was set to auto-adjusting positive airway pressure mode (APAP) at a pressure range of 6 to 20 cm H
2O. The adherence report consisted of information regarding the time of PAP usage, pressure requirements, residual respiratory events, and mask leak. The APAP machine adjusts the pressure automatically based on a proprietary algorithm. The data recovered from APAP machine included the participant’s hourly and daily usage, 95th percentile air pressure, AHI, and mask air leak. Participants were instructed to wear their APAP throughout the study. A person is considered compliant with the CPAP if they use CPAP ≥ 4 hours a night for at least 70% of the nights.
14 (link)
All measurements were taken 3 months prior to recruitment with the PAP only and over a 4-week period with combination therapy (APAP-MAD).
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All participants used a ResMed AirSense 10 AutoSet machine with the ability to automatically upload adherence data to ResMed AirViewTM (cloud-based system) or from an SD card for review. The patient’s machine was set to auto-adjusting positive airway pressure mode (APAP) at a pressure range of 6 to 20 cm H
2O. The adherence report consisted of information regarding the time of PAP usage, pressure requirements, residual respiratory events, and mask leak. The APAP machine adjusts the pressure automatically based on a proprietary algorithm. The data recovered from APAP machine included the participant’s hourly and daily usage, 95th percentile air pressure, AHI, and mask air leak. Participants were instructed to wear their APAP throughout the study. A person is considered compliant with the CPAP if they use CPAP ≥ 4 hours a night for at least 70% of the nights.
14 (link)
All measurements were taken 3 months prior to recruitment with the PAP only and over a 4-week period with combination therapy (APAP-MAD).
3
Obstructive Sleep Apnea Diagnosis and CPAP Titration
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OSA diagnosis was established in the local pneumology clinic by ambulatory or in-hospital six-channel cardiorespiratory polygraphy (Philips Respironics Alice Night One or DeVilbiss Porti 7). All recordings were manually scored by a trained pneumologist, according to the guidelines of the American Academy of Sleep Medicine (AASM). Apnea was defined as a complete cessation of airflow for a minimum of 10 s. Hypopnea was defined as a >50% reduction in airflow for a minimum of 10 s, associated with a ≥3% decrease in peripheral oxygen saturation or an arousal. Patients with AHI of 15–30 and >30 were considered to have moderate and severe OSA, respectively. CPAP effective pressure autotitration was performed in the sleep laboratory using Philips Respironics DreamStation Auto CPAP or a Resmed Airsense 10 Autoset.
4
CPAP Therapy Effectiveness for Sleep Disorders
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Intervention arm: Participants that are allocated to the CPAP arm will be provided with a CPAP machine (ResMed Airsense 10 Autoset™). Each patient in the CPAP arm will be given an appropriate mask, connecting hose, a heated humidifier, and all the necessary accessories to operate the CPAP equipment for the duration of the trial. This machine features built-in wireless connectivity capability to monitor compliance remotely via a secured website, AirView (AV); AutoRamp™ with sleep onset detection; expiratory pressure relief and Easy-Breathe technology, allowing a suitably qualified person to remotely change settings to improve patient compliance and comfort if required.
Control arm: Νο treatment.
Control arm: Νο treatment.
5
Noninvasive Respiratory Devices in AHRF
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The performances of Bag-CPAP and of four other noninvasive devices were compared with those of an ICU ventilator (Puritan Bennett 980™; Covidien, Dublin, Ireland). The four tested devices were: one homecare CPAP ventilator (AirSense™ 10 AutoSet™; Resmed, Saint Priest, France); two virtual valve CPAP devices (Boussignac CPAP; Vygon, Ecouen, France, and O-two CPAP; O-two, Brampton, Canada), and one CPAP mask with a Venturi system (StarMed™ Ventumask CPAP; Intersurgical, Wokingham, United Kingdom). These devices were chosen to cover a large range of CPAP mechanisms available for patients with AHRF. Characteristics of each device are summarized in Additional file 1 : Table S1. The PB 980 ventilator was used as the gold standard in bench test evaluation.
6
Comparison of CPAP and PVI Treatments for Sleep Apnea
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In patients who were randomized to CPAP therapy (AirSense 10 Autoset, ResMed Inc., San Diego, California), we selected the auto set mode for CPAP pressure (between 3 and 15 cm H 2 O) during tolerance testing. Data were downloaded from the CPAP software (RescanÒ, ResMed) to estimate the residual AHI.
Treatment PVI was performed using conscious sedation (midazolam and fentanyl). Five experienced operators performed all the procedures. PVI was achieved with cryoballoon ablation (28-mm Arctic Front Advance cryoballoon catheter and Achieve pulmonary vein catheter; Medtronic Inc.) or radiofrequency (RF) ablation [CARTO 3 (Biosense webster, Diamond Bar, California) system with ThermoCool SmartTouch ablation catheter (Biosense webster) and 12-or 22-polar Lasso pulmonary vein catheter (Johnson & Johnson, New Brunswick, New Jersey)]. Antiarrhythmic drugs were routinely used for 6-8 weeks after PVI. Ablation was considered a failure if antiarrhythmic drugs had to be continued beyond, or reinstituted after, the blanking period.
Treatment PVI was performed using conscious sedation (midazolam and fentanyl). Five experienced operators performed all the procedures. PVI was achieved with cryoballoon ablation (28-mm Arctic Front Advance cryoballoon catheter and Achieve pulmonary vein catheter; Medtronic Inc.) or radiofrequency (RF) ablation [CARTO 3 (Biosense webster, Diamond Bar, California) system with ThermoCool SmartTouch ablation catheter (Biosense webster) and 12-or 22-polar Lasso pulmonary vein catheter (Johnson & Johnson, New Brunswick, New Jersey)]. Antiarrhythmic drugs were routinely used for 6-8 weeks after PVI. Ablation was considered a failure if antiarrhythmic drugs had to be continued beyond, or reinstituted after, the blanking period.
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