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The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

ABSTRACT: STUDY OBJECTIVES:The main objective of this study was to evaluate the role of sham continuous positive airway pressure (CPAP) compared to conservative medical therapy (CMT) as a control arm in the Best Apnea Interventions for Research (BestAIR) study by assessing differences in subjectively and objectively measured outcomes, adverse events, adherence, and retention rates. METHODS:BestAIR is a clinical trial aimed to identify important design features for future randomized controlled trials of CPAP. Participants with obstructive sleep apnea were randomized to one of four groups; two control arms (CMT, sham-CPAP) and two active CPAP arms (with and without behavioral interventions). Blood pressure and health-related quality of life outcomes were assessed at baseline, 6 and 12 months. Study outcomes, retention, and adverse event rates were compared between the two control arms. Sham-CPAP adherence and self-efficacy were also compared to active-CPAP adherence (without behavioral intervention). RESULTS:Our sample included 86 individuals in the control arms and 42 participants in the active-CPAP arm. There were no differences in longitudinal profiles in blood pressure, health-related quality of life outcomes, dropout rates, or adverse events in sham-CPAP group compared to CMT-only group (all ps > 0.05); standardized differences were generally small and with inconsistent directionality across measurements. When compared to active-CPAP, sham-CPAP was associated with 93 fewer minutes/night of usage over 12 months (p = 0.007) and lower outcome expectations (p < 0.05). CONCLUSION:We observed no evidence of differences in objectively or subjectively measured outcomes with the use of sham-CPAP compared to CMT group. The lower adherence on sham-CPAP and poorer self-efficacy compared to active-CPAP may suggest differences in perceived benefit. REGISTRATION:NCT01261390 Best Apnea Interventions for Research (BestAIR) www.clinicaltrials.gov.

SUBMITTER: Reid ML

PROVIDER: S-EPMC7182666 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

Reid Michelle L ML Gleason Kevin J KJ Bakker Jessie P JP Wang Rui R Mittleman Murray A MA Redline Susan S

Sleep 20190801 8

<h4>Study objectives</h4>The main objective of this study was to evaluate the role of sham continuous positive airway pressure (CPAP) compared to conservative medical therapy (CMT) as a control arm in the Best Apnea Interventions for Research (BestAIR) study by assessing differences in subjectively and objectively measured outcomes, adverse events, adherence, and retention rates.<h4>Methods</h4>BestAIR is a clinical trial aimed to identify important design features for future randomized controll ...[more]

PMID: 31116848

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Project description:Background Studies have shown that a significant percentage of patients with obstructive sleep apnea (OSA) do not tolerate continuous positive airway pressure (CPAP) therapy and long-term use may be as low as 30%. Given the lower levels of symptoms and health-related risks, patients with mild sleep apnea may be at even higher risk for non-adherence to long term CPAP. The purpose of our study was to investigate the prevalence and associations of long-term CPAP adherence in first time users with mild sleep apnea diagnosed by home sleep apnea testing (HSAT). Methods We identified all the patients who were diagnosed with mild sleep apnea (5 = < AHI < 15) by home sleep apnea testing from 01/2013 to 06/2019 at a large, combined community and hospital-based sleep practice. Only first time CPAP users were included. Compliance was defined as CPAP usage ≥ 4 h per night on ≥ 70% of nights over 30 consecutive days. We defined long term adherence as compliance on the 12th month following CPAP set up. Patient demographics, comorbidities, and CPAP compliance at 1st, 3rd, 6th, 9th and 12th month after therapy initiation were collected. We compared and identified the factors that had significant difference (P < 0.1) between compliant and non-compliant groups at the 12th month. Results 222 patients were included in the analysis. 57 (25.7%) patients were adherent with long term CPAP treatment. The following factors were associated with a greater likelihood for long-term CPAP adherence: older age, lower body mass index (BMI), presence of a bed partner, non-smoker, presence of Diabetes Mellitus (DM), presence of Heart Failure (CHF), lack of depression, and compliance at 1st, 3rd, 6th and 9th month. Conclusions Long term CPAP compliance in mild sleep apnea patients is low. Long term adherence to CPAP can be predicted based on CPAP adherence during the first three months. Supplementary Information The online version contains supplementary material available at 10.1186/s12890-023-02612-3.

Project description:Study objectiveTo determine the neurocognitive effects of continuous positive airway pressure (CPAP) therapy on patients with obstructive sleep apnea (OSA).Design, setting, and participantsThe Apnea Positive Pressure Long-term Efficacy Study (APPLES) was a 6-month, randomized, double-blind, 2-arm, sham-controlled, multicenter trial conducted at 5 U.S. university, hospital, or private practices. Of 1,516 participants enrolled, 1,105 were randomized, and 1,098 participants diagnosed with OSA contributed to the analysis of the primary outcome measures.InterventionActive or sham CPAP MEASUREMENTS: THREE NEUROCOGNITIVE VARIABLES, EACH REPRESENTING A NEUROCOGNITIVE DOMAIN: Pathfinder Number Test-Total Time (attention and psychomotor function [A/P]), Buschke Selective Reminding Test-Sum Recall (learning and memory [L/M]), and Sustained Working Memory Test-Overall Mid-Day Score (executive and frontal-lobe function [E/F])ResultsThe primary neurocognitive analyses showed a difference between groups for only the E/F variable at the 2 month CPAP visit, but no difference at the 6 month CPAP visit or for the A/P or L/M variables at either the 2 or 6 month visits. When stratified by measures of OSA severity (AHI or oxygen saturation parameters), the primary E/F variable and one secondary E/F neurocognitive variable revealed transient differences between study arms for those with the most severe OSA. Participants in the active CPAP group had a significantly greater ability to remain awake whether measured subjectively by the Epworth Sleepiness Scale or objectively by the maintenance of wakefulness test.ConclusionsCPAP treatment improved both subjectively and objectively measured sleepiness, especially in individuals with severe OSA (AHI > 30). CPAP use resulted in mild, transient improvement in the most sensitive measures of executive and frontal-lobe function for those with severe disease, which suggests the existence of a complex OSA-neurocognitive relationship.Clinical trial informationRegistered at clinicaltrials.gov. Identifier: NCT00051363.CitationKushida CA; Nichols DA; Holmes TH; Quan SF; Walsh JK; Gottlieb DJ; Simon RD; Guilleminault C; White DP; Goodwin JL; Schweitzer PK; Leary EB; Hyde PR; Hirshkowitz M; Green S; McEvoy LK; Chan C; Gevins A; Kay GG; Bloch DA; Crabtree T; Demen WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2012;35(12):1593-1602.

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The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

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The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

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