Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial

IMPORTANCE There are no established measures to prevent nocturnal breathing disturbances and other altitude-related adverse health effects (ARAHEs) among lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude. OBJECTIVE To evaluate whether nocturnal oxygen therapy (NOT) prevents nocturnal hypoxemia and breathing disturbances during the first night of a stay at 2048 m and reduces the incidence of ARAHEs. DESIGN, SETTING, AND PARTICIPANTS This randomized, placebo-controlled crossover trial was performed from January to October 2014 with 32 patients with COPD living below 800 m with forced expiratory volume in the first second of expiration (FEV 1) between 30% and 80% predicted, pulse oximetry of at least 92%, not requiring oxygen therapy, and without history of sleep apnea. Evaluations were performed at the University Hospital Zurich (490 m, baseline) and during 2 stays of 2 days and nights each in a Swiss Alpine hotel at 2048 m while NOT or placebo treatment was administered in a randomized order. Between altitude sojourns, patients spent at least 2 weeks

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“…The coprimary outcomes were analyzed by intention-to-treat, with missing data replaced by multiple imputations, and per-protocol. 22…”

Section: Discussionmentioning

confidence: 99%

Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters

et al. 2020

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“…This results in an inconsistency of criteria used across studies, which can influence the final conclusion of the results and limits comparability. For example, out of the three RCTs used in this study, one assumed a change of 2 points to be important,15 and two did not report a prespecified criterion and relied on statistical significance of the treatment effect 14 16. Our robust calculation of the MID means that clinicians and researchers can now confidently use an MID that is based on strong evidence.…”

Section: Discussionmentioning

confidence: 99%

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Crook

Sievi

Bloch

et al. 2018

Thorax

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BackgroundThe Epworth Sleepiness Scale (ESS) is a widely used tool for assessing sleepiness in patients with obstructive sleep apnoea (OSA). We aimed to estimate the minimal important difference (MID) in patients with OSA.MethodsWe used individual data from three randomised controlled trials (RCTs) in patients with OSA where the preintervention to postintervention change in ESS was used as a primary outcome. We used anchor-based linear regression and responder analysis approaches to estimate the MID. For anchors, we used the change in domains of the Functional Outcomes of Sleep Questionnaire and 36-Item Short Form Health Survey. We also used the distribution-based approaches Cohen’s effect size, SE of measurement and empirical rule effect size to support the anchor-based estimates. The final MID was determined by triangulating all estimates to a single MID.FindingsA total of 639 patients with OSA were included in our analyses across the three RCTs with a median (IQR) baseline ESS score of 10 (6–13). The median (IQR) ESS change score overall was −2 (−5 to 1). The anchor-based estimates of the MID were between −1.74 and −4.21 points and estimates from the responder analysis were between −1 and −3 points. Distribution-based estimates were smaller, ranging from −1.46 to −2.36.InterpretationWe propose an MID for the ESS of 2 points in patients with OSA with a disease severity from mild to severe. This estimate provides the means to plan trials and interpret the clinical relevance of changes in ESS.Trial registration numberProvent, NCT01332175; autoCPAP trial, NCT00280800; MOSAIC,ISRCTN (3416388).

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“…Some studies 10,11) have reported that fixed-pressure CPAP was more effective at reducing BP than auto-adjusting CPAP. Meanwhile, one recent study 12) reported that auto-adjusting CPAP and fixed-pressure CPAP are equivalent in terms of BP reduction. The question of which form of CPAP, i.e.…”

Section: Effect Of Cpap Titration On Sa Patients With Hypertensionmentioning

confidence: 99%

Effects of Continuous Positive Airway Pressure Titration on Nocturnal Blood Pressure Fluctuation in Severe Sleep Apnea Patients with Hypertension

Sekizuka

Hoshide

Osada

et al. 2019

J St. Marianna Univ

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This case report presents two hypertensive patients with severe sleep apnea (SA) who were effectively treated with optimized SA therapy using manual continuous positive airway pressure (CPAP) titration. Case 1: A 52-year old woman was receiving treatment for severe obstructive SA and hypertension. She noticed residual drowsiness after the initiation of auto-adjusting CPAP. After manual CPAP titration, her sleepiness improved, and home blood pressure (BP) values were almost completely controlled, despite the reduced use of antihypertensives. Case 2: A 68-year old man with chronic heart failure was receiving treatment for severe SA by means of autoadjusting CPAP. A favorable decrease in morning BP was observed after manual CPAP titration.Remarkable antihypertensive effects were observed in hypertensive patients with severe SA after administering individualized and optimized CPAP therapy. SA treatment that is optimized with CPAP titration should be considered as an approach for strict antihypertensive management in hypertensive SA patients.

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Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial

Abstract: ClinicalTrials.gov NCT00280800.

Cited by 30 publications

References 30 publications

Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters

Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Effects of Continuous Positive Airway Pressure Titration on Nocturnal Blood Pressure Fluctuation in Severe Sleep Apnea Patients with Hypertension

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