scholarly journals A Randomized Crossover Trial of a Pressure Relief Technology (SensAwake™) in Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Richard K. Bogan ◽  
Charles Wells
Keyword(s):  
Sleep Quality ◽  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Pressure Relief ◽  
Quality Outcomes ◽  
Cpap Adherence ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep ◽  
Cpap Devices

Objectives/Background. Improving adherence to CPAP devices is crucial to reduce the long-term morbidity associated with OSA. SensAwake is a unique pressure relief technology that aims to promptly reduce the pressure upon sensing irregular respiration indicative of wakefulness. The purpose of this study was to compare adherence and sleep-quality outcomes in patients treated by CPAP with and without SensAwake technology.Methods. Participants with moderate-to-severe OSA were randomized to use CPAP devices with or without SensAwake (4 weeks) before crossing over.Results. Sixty-five patients completed both arms of the trial. There were no statistically significant differences in CPAP adherence with or without SensAwake over the study period (SensAwake ON272.67±17.06versus SensAwake OFF289.09±15.24;p=0.180). SensAwake reported a significantly lower system leak, 90th percentile leak, and time spent with excessive (>60 L/min) leak. Subgroup analysis suggested a trend towards improved adherence in patients with moderate-to-severe insomnia when using SensAwake.Conclusions. Using SensAwake incurred benefit in terms of reduced leaks; however, SensAwake did not improve CPAP adherence or objective sleep quality. Further studies should investigate the accuracy of observed trends towards increased adherence using SensAwake among patients with OSA and insomnia.

scholarly journals 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 ◽  
2021 ◽  
Vol 57 (9) ◽  
pp. 915
Author(s):  
Yen-Lung Chen ◽  
Li-Pang Chuang ◽  
Shih-Wei Lin ◽  
Hung-Yu Huang ◽  
Geng-Hao Liu ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Continuous Positive Airway Pressure ◽  
Sleep Quality ◽  
Airway Pressure ◽  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Cpap Therapy ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep

Backgroundand Objectives: 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. Materials and Methods: 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. Results: 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 [p = 0.032] and 8.6 ± 3.0 vs. 9.2 ± 2.9 [p = 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 [p = 0.023]). Conclusions: 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.

Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management

2020 ◽  
pp. 002203452095697
Author(s):  
E. Schneiderman ◽  
P. Schramm ◽  
J. Hui ◽  
P. D. Wilson ◽  
P. Moura ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Mouth Opening ◽  
Oral Appliance ◽  
Oral Appliances ◽  
Pressure Therapy ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep ◽  
Respiratory Event ◽  
Test Population

The effectiveness and predictability of 2 different oral appliance (OA) designs to reduce the respiratory event index (REI) in moderate and severe obstructive sleep apnea (OSA) patients requires elucidation. The primary aim of the trial was to determine if 2 widely used midline-traction and bilateral-thrust OA designs differ in effectiveness to reduce the REI within a single test population categorized by OSA severity. Moderate and severe adult OSA patients, who were previously prescribed continuous positive airway pressure therapy (CPAP) but were dissatisfied with it ( n = 56), were studied by home-polygraphy in a randomized crossover trial using either midline-traction with restricted mouth opening (MR) or bilateral thrust with opening permitted (BP) design OAs. OAs were used nightly for 4 wk (T2) followed by a 1-wk washout period, then 4 wk (T4) using the alternate OA. REI and oxygen saturation (SaO2) were primary outcomes, while predictability and efficacy comparison of the 2 OAs were secondary outcomes. Thirty-six participants had used MR and BP OAs during both 4-wk study legs. Twenty (55.6%) MR OA-using participants, 25 (69.4%) BP OA-using participants, and 16 (44.4%) participants using both OAs had significant REI reductions. Overall baseline (T0) median REI (interquartile range) of 33.7 (20.7–54.9) was reduced to 18.0 (8.5–19.4) at T2 and to 12.5 (8.2–15.9) at T4 ( P < 0.001). Comparison of the 2 sequence groups’ (MR-BP and BP-MR) REI showed the median differences between T0 and T2 and T4 were highly significant ( P < 0.001). Regression analysis predicted about half of all users will have REIs between 8 and 16 after 2 mo. Baseline overjet measures >2.9 mm predicted greater OA advancement at T4. Mean and minimum SaO2 did not change significantly from T0 to T2 or T4. MR and BP OA designs similarly attenuated REI in moderate and severe OSA individuals who completed the 8-wk study protocol with greater REI reduction in those with severe OSA (ClinicalTrials.gov NCT03219034).

Evaluating the effectiveness of patient education and the feasibility of health technology (eHealth interventions) in improving sleep quality and blood pressure secondary to greater adherence to continuous positive airway pressure ventilation in persons with obstructive sleep apnoea: A literature review (Preprint)

2021 ◽  
Author(s):  
Rabie Adel Abdel-Kar El Arab
Keyword(s):  
Blood Pressure ◽  
Continuous Positive Airway Pressure ◽  
Patient Education ◽  
Sleep Quality ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Sleep Apnoea ◽  
Cpap Adherence ◽  
Obstructive Sleep ◽  
Positive Airway Pressure Ventilation

UNSTRUCTURED Obstructive sleep apnoea is a highly burdensome condition that predominantly affects adults and not only impairs daily functioning but also confers a heightened risk of adverse cardiovascular health, particularly among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the growing era of high population demand and rising complexity, greater efforts are needed at the individual level if outcomes are to improve in the future. Therefore, this literature review sought to explore the effect of patient education upon sleep quality and blood pressure as secondary effects of CPAP adherence in adults. A search for relevant literature was performed using MEDLINE, EMBASE and the Cochrane library. Articles were restricted to peer-review, English language and publication in the last 10 years. Articles were appraised using CASP, relevant data was extracted using systematic proformas and the outcomes were analysed using descriptive analysis and narrative synthesis. Nine studies were included in the first analysis where there was a highly significant association between education provision and CPAP adherence (MD=1.19 hours/night, Z=3.67, p=0.0002), than compared to usual care. The second analysis was informed from five studies and this showed a positive association between education and sleep quality, but the effect was marginally insignificant (MD=0.54, Z=1.89, p=0.06), than compared to usual care. Both analyses were not affected by inter-study heterogeneity (both p<0.01). Overall, this review showed that the provision of education with moderate to high intensity provides meaningful effects upon CPAP adherence and sleep quality. Narrative findings also revealed improvements in blood pressure and other health outcomes, which are supported by previous studies. Despite some limitations, care providers should be proactivity in education provision using a continuous approach through the disease course as this is likely to lead to improvements in outcomes. Finally, future research is needed in the form of a high-quality randomised trial to help explore the effects of education delivered through eHealth mediums.

scholarly journals Long-term effect of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ryutaro Shirahama ◽  
Takeshi Tanigawa ◽  
Yoshifumi Ida ◽  
Kento Fukuhisa ◽  
Rika Tanaka ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Obstructive Sleep Apnea ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Cpap Therapy ◽  
Cpap Adherence ◽  
Obstructive Sleep

AbstractObstructive sleep apnea (OSA) is a common cause of hypertension. Previous studies have demonstrated beneficial short-term effects of continuous positive airway pressure (CPAP) therapy on blood pressure. However, long-term antihypertensive effects of CPAP have not been properly verified. This study examined the longitudinal effect of CPAP therapy adherence on blood pressure among OSA patients. All patients diagnosed with OSA and undergoing subsequent CPAP therapy at a Kanagawa-area sleep clinic were clinically followed for 24 months to examine CPAP adherence, as well as longitudinal changes in blood pressure and body weight because it may become a confound factor for changes in blood pressure. The hours of CPAP usage were collected over the course of 30 nights prior to each follow-up visit (1st, 3rd, 6th, 12th, and 24th month). The relationship between CPAP adherence and blood pressure was analyzed using mixed-effect logistic regression models. A total of 918 OSA patients were enrolled in the study. We found a significant reduction in diastolic blood pressure among patients with good CPAP adherence during the 24-month follow-up period (β = − 0.13, p = 0.03), when compared to the group with poor CPAP adherence. No significant association was found between CPAP adherence and weight loss (β = − 0.02, p = 0.59). Long-term, good CPAP therapy adherence was associated with lower diastolic blood pressure without significant weight loss.

scholarly journals Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e015836 ◽  
Author(s):  
Jean Louis Pepin ◽  
Frédéric Gagnadoux ◽  
Alison Foote ◽  
Rachel Vicars ◽  
Bhavi Ogra ◽  
...  
Keyword(s):  
Continuous Positive Airway Pressure ◽  
Sleep Quality ◽  
Obstructive Sleep Apnoea ◽  
Airway Pressure ◽  
Primary Outcome ◽  
Positive Airway Pressure ◽  
Sleep Onset ◽  
Sleep Apnoea ◽  
Pressure Relief ◽  
Obstructive Sleep

IntroductionObstructive sleep apnoea (OSA) is a common sleep breathing disorder affecting up to 17% of the middle-aged population. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA, but acceptance and adherence to therapy is suboptimal in specific subgroups particularly those with insomnia or poor sleep quality (40%–80% of patients with OSA). Pressure intolerance, particularly during periods of wakefulness, inhibiting sleep onset or return to sleep, is one reason for poor CPAP adherence. AutoCPAPs continually monitor airflow changes and only increase the pressure when the upper airway requires it. Reducing the pressure during wakefulness-sleep transition and wakefulness-after-sleep-onset (WASO) may improve therapy comfort and potentially adherence without compromising therapy efficacy. We hypothesise that SensAwake, a pressure relief function that reduces CPAP pressure on the transition from sleep to wakefulness and on WASO, may improve objective sleep quality.Methods and analysisThis is a multicentre, randomised double-blind crossover clinical trial on patients with both OSA and insomnia. Insomnia is defined as Insomnia Severity Index >15 at screening. Baseline data, including actigraphy, are collected for 1 week before randomisation (1:1) to either conventional AutoCPAP or AutoCPAP with SensAwake for 4 weeks. After an evaluation visit, patients are switched to the other treatment arm for a further 4 weeks. Allowing for 20% dropout, 48 patients are required. If applicable, repeated measures analysis of variance will be used to assess differences in WASO measured by actigraphy (primary outcome), other actigraphy measures, AutoCPAP compliance, subjective questionnaire scores (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Short-Form 12 Health Survey) and 24 hours blood pressure (secondary outcomes).Ethics and disseminationThe protocol was approved by the regional Ethics Committee (CPP Sud-Est–V, IRB N°6705) on 9 December 2015, is registered on ClincalTrials.gov (NCT02721329) and started in June 2016 with expected publication of primary outcome results in 2018.Trial registration numberNCT0272132; Pre-results.

Evaluating the effectiveness of patient education and the feasibility of health technology (eHealth interventions) in improving sleep quality and blood pressure secondary to greater adherence to continuous positive airway pressure ventilation in persons with obstructive sleep apnoea: A literature review (Preprint)

2021 ◽  
Author(s):  
Rabie El Arab
Keyword(s):  
Blood Pressure ◽  
Continuous Positive Airway Pressure ◽  
Patient Education ◽  
Sleep Quality ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Sleep Apnoea ◽  
Cpap Adherence ◽  
Obstructive Sleep ◽  
Positive Airway Pressure Ventilation

UNSTRUCTURED Obstructive sleep apnoea is a highly burdensome condition that predominantly affects adults and not only impairs daily functioning but also confers a heightened risk of adverse cardiovascular health, particularly among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the growing era of high population demand and rising complexity, greater efforts are needed at the individual level if outcomes are to improve in the future. Therefore, this literature review sought to explore the effect of patient education upon sleep quality and blood pressure as secondary effects of CPAP adherence in adults. A search for relevant literature was performed using MEDLINE, EMBASE and the Cochrane library. Articles were restricted to peer-review, English language and publication in the last 10 years. Articles were appraised using CASP, relevant data was extracted using systematic proformas and the outcomes were analysed using descriptive analysis and narrative synthesis. Nine studies were included in the first analysis where there was a highly significant association between education provision and CPAP adherence (MD=1.19 hours/night, Z=3.67, p=0.0002), than compared to usual care. The second analysis was informed from five studies and this showed a positive association between education and sleep quality, but the effect was marginally insignificant (MD=0.54, Z=1.89, p=0.06), than compared to usual care. Both analyses were not affected by inter-study heterogeneity (both p<0.01). Overall, this review showed that the provision of education with moderate to high intensity provides meaningful effects upon CPAP adherence and sleep quality. Narrative findings also revealed improvements in blood pressure and other health outcomes, which are supported by previous studies. Despite some limitations, care providers should be proactivity in education provision using a continuous approach through the disease course as this is likely to lead to improvements in outcomes. Finally, future research is needed in the form of a high-quality randomised trial to help explore the effects of education delivered through eHealth mediums.

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