Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial

<i>Background</i><i>and Objectives</i>: Obstructive sleep apnea (OSA) patients may remove their mask unconsciously during automatic continuous positive airway pressure (Auto-CPAP) therapy and therefore cannot receive good treatment. The discomfort from the airflow of Auto-CPA...

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Main Authors: Yen-Lung Chen, Li-Pang Chuang, Shih-Wei Lin, Hung-Yu Huang, Geng-Hao Liu, Hung-Fu Hsu, Ning-Hung Chen
Format: Article
Language:English
Published: MDPI AG 2021-08-01
Series:Medicina
Subjects:
Online Access:https://www.mdpi.com/1648-9144/57/9/915
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author Yen-Lung Chen
Li-Pang Chuang
Shih-Wei Lin
Hung-Yu Huang
Geng-Hao Liu
Hung-Fu Hsu
Ning-Hung Chen
author_facet Yen-Lung Chen
Li-Pang Chuang
Shih-Wei Lin
Hung-Yu Huang
Geng-Hao Liu
Hung-Fu Hsu
Ning-Hung Chen
author_sort Yen-Lung Chen
collection DOAJ
description <i>Background</i><i>and Objectives</i>: Obstructive sleep apnea (OSA) patients may remove their mask unconsciously during automatic continuous positive airway pressure (Auto-CPAP) therapy and therefore cannot receive good treatment. The discomfort from the airflow of Auto-CPAP may be one reason for interrupted sleep. Sens Awake (SA) can detect the arousal and lower the pressure to prevent patients from fully awakening from sleep. <i>Materials and Methods</i>: To evaluate the effect of SA, we designed a prospective, randomized, crossover trial comparing Auto-CPAP with and without SA on Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Nasal Obstruction Symptom Evaluation (NOSE) Scale and recorded data from the auto-CPAP machine. <i>Results</i>: In the 25 patients who completed the study, the gender, age, body mass index, neck circumference, polysomnography data, and previous CPAP use were not significantly different between the two arms. The average and 90th percentile pressures were significantly lower during SA on (SA on vs. off: 6.9 ± 2.7 vs. 7.3 ± 2.6 [<i>p</i> = 0.032] and 8.6 ± 3.0 vs. 9.2 ± 2.9 [<i>p</i> = 0.002], respectively). The time used, days used, compliance, average and 90th percentile leaks, and the residual Apnea-Hypopnea Index (AHI) were not significantly changed between the SA on-and-off. Based on the subjective evaluation, PSQI, ESS, and NOSE were not significantly different between the SA on-and-off; however, based on additional analyses which were compared with baseline data, the ESS was significantly lower when the SA was on (SA on vs. baseline: 11.1 ± 6.1 vs. 13.2 ± 6.0 [<i>p</i> = 0.023]). <i>Conclusions</i>: CPAP therapy with or without two weeks of the SA had a similar effect on CPAP use, sleep quality, daytime sleepiness, and nasal obstruction. The SA may have a tendency to improve daytime sleepiness, but needs further study with a longer duration of treatment.
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spelling doaj.art-2b1d7e5a91cd43e9a207ffd0ebbd641e2023-11-22T14:08:13ZengMDPI AGMedicina1010-660X1648-91442021-08-0157991510.3390/medicina57090915Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover TrialYen-Lung Chen0Li-Pang Chuang1Shih-Wei Lin2Hung-Yu Huang3Geng-Hao Liu4Hung-Fu Hsu5Ning-Hung Chen6Sleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, TaiwanSleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, TaiwanSleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, TaiwanSleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, TaiwanSleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, TaiwanDepartment of Industrial Design, Chang Gung University, Taoyuan 33302, TaiwanSleep Center, Chang Gung Memorial Hospital, Taoyuan 33378, Taiwan<i>Background</i><i>and Objectives</i>: Obstructive sleep apnea (OSA) patients may remove their mask unconsciously during automatic continuous positive airway pressure (Auto-CPAP) therapy and therefore cannot receive good treatment. The discomfort from the airflow of Auto-CPAP may be one reason for interrupted sleep. Sens Awake (SA) can detect the arousal and lower the pressure to prevent patients from fully awakening from sleep. <i>Materials and Methods</i>: To evaluate the effect of SA, we designed a prospective, randomized, crossover trial comparing Auto-CPAP with and without SA on Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Nasal Obstruction Symptom Evaluation (NOSE) Scale and recorded data from the auto-CPAP machine. <i>Results</i>: In the 25 patients who completed the study, the gender, age, body mass index, neck circumference, polysomnography data, and previous CPAP use were not significantly different between the two arms. The average and 90th percentile pressures were significantly lower during SA on (SA on vs. off: 6.9 ± 2.7 vs. 7.3 ± 2.6 [<i>p</i> = 0.032] and 8.6 ± 3.0 vs. 9.2 ± 2.9 [<i>p</i> = 0.002], respectively). The time used, days used, compliance, average and 90th percentile leaks, and the residual Apnea-Hypopnea Index (AHI) were not significantly changed between the SA on-and-off. Based on the subjective evaluation, PSQI, ESS, and NOSE were not significantly different between the SA on-and-off; however, based on additional analyses which were compared with baseline data, the ESS was significantly lower when the SA was on (SA on vs. baseline: 11.1 ± 6.1 vs. 13.2 ± 6.0 [<i>p</i> = 0.023]). <i>Conclusions</i>: CPAP therapy with or without two weeks of the SA had a similar effect on CPAP use, sleep quality, daytime sleepiness, and nasal obstruction. The SA may have a tendency to improve daytime sleepiness, but needs further study with a longer duration of treatment.https://www.mdpi.com/1648-9144/57/9/915continuous positive airway pressurenasal obstructiondisorders of excessive somnolenceobstructive sleep apnea
spellingShingle Yen-Lung Chen
Li-Pang Chuang
Shih-Wei Lin
Hung-Yu Huang
Geng-Hao Liu
Hung-Fu Hsu
Ning-Hung Chen
Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
Medicina
continuous positive airway pressure
nasal obstruction
disorders of excessive somnolence
obstructive sleep apnea
title Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
title_full Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
title_fullStr Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
title_full_unstemmed Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
title_short Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial
title_sort effects of pressure control device sensawake™ on obstructive sleep apnea osa patients who remove the mask for unknown reasons during automatic continuous positive airway pressure auto cpap therapy a prospective randomized crossover trial
topic continuous positive airway pressure
nasal obstruction
disorders of excessive somnolence
obstructive sleep apnea
url https://www.mdpi.com/1648-9144/57/9/915
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