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Positive airway pressure (PAP) associated claustrophobia is common among obstructive sleep apnea patients and plays a prominent role in low adherence and treatment failure. As there are no evidence-based interventions for PAP-associated claustrophobia, the objective of the present research is to pilot test Mindfulness-based Exposure for PAP-associated Claustrophobia, in sleep apnea adults that present with treatment non-adherence and claustrophobia. This approach combines Mindfulness-based Stress Reduction with exposure-based treatment components to target this treatment-associated claustrophobia. The present article outlines the mindfulness exposure intervention design and methods and reports the pilot trial study protocol. Trial findings are intended to: (a) develop a preliminary effect size of the intervention on PAP-associated claustrophobia; (b) explore differences in treatment adherence by group (intervention vs control); and (c) establish feasibility for expanded protocol implementation, delivery, and participant acceptability of the intervention to support subsequent design of a fully powered randomized controlled trial. [ABSTRACT FROM AUTHOR]

Abstract Precision medicine is expected to impact the care of people with asthma, given its high disease prevalence, heterogeneity of pathophysiologic mechanisms, and consequent clinical phenotypes. A novel phenotype-stratified clinical trial conducted by the NHLBI AsthmaNet Consortium, titled Steroids in Eosinophil Negative Asthma (SIENA), was a randomized, multicenter, clinical trial that prospectively stratified individuals according to their baseline level of sputum inflammation during a screening period. Two phenotypic strata were assigned based on an a priori defined extent of sputum eosinophilia (Eos Low versus Eos High). This article describes: the scientific premise for the trial design, including assumptions used for power calculations; modifications to the analysis plan implemented after the trial started due to a higher than expected prevalence of one phenotypic stratum which impacted the ability to accrue sufficient subjects within the planned budget and study period; investigator alternatives to address the strata imbalance weighing scientific impact and study feasibility; and the final modified SIENA study design and analysis plan. SIENA was successfully completed in a manner that maintained meaningful outcomes. We conclude with recommendations for incorporation of pre-specified contingency plans into phenotype-directed protocols, to address the potential for differences in observed compared to estimated prevalence of different phenotypes in a study population. These approaches can be applied to precision medicine trials for the future. [ABSTRACT FROM AUTHOR]

The article presents a randomized clinical trial, Best Adjustment Strategy for Asthma in the Long Term (BASALT) to determine the adjustments of inhaled corticosteroid therapy in preventing treatment failure in adults with mild to moderate asthma. The study concluded that the adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy. It is suggested to use symptom-based adjustment strategies because it is simple to use and empower patients.