Nasal Dilator Strip is an Effective Placebo Intervention for Severe Obstructive Sleep Apnea

Yagihara, Fabiana; Lorenzi-Filho, Geraldo; Santos-Silva, Rogério

doi:10.5664/jcsm.6450

Cited by 17 publications

(15 citation statements)

References 39 publications

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“…The institutional ethics committee approved this study (SDC 3230/08/146). Overnight use of a nasal strip is well accepted by patients, and improves subjective daytime sleepiness and depressive symptoms without significant effects in OSA severity ( 13 ).…”

Section: Methodsmentioning

confidence: 99%

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The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic

Cruz

Drager

Queiróz

et al. 2021

Clinics

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OBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m 2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.

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Section: Methodsmentioning

confidence: 99%

“…The nasal dilator is supplied to participants in all visits. Nasal dilator has been shown to be a good placebo for studies testing the effects of CPAP ( 13 ).…”

Section: Methodsmentioning

confidence: 99%

The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic

Cruz

Drager

Queiróz

et al. 2021

Clinics

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“…Patients in the control group were discharged after overnight PSG and provided with nasal strips (Breathe Right ® ; GSK, United Kingdom) of various sizes. These are a proven placebo therapy in this context, and might reduce nasal resistance but have no effect on the degree of OSA or snoring in clinical trials [ 20 ].…”

Section: Methodsmentioning

confidence: 99%

Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction

et al. 2020

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Background Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality. Objectives The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO 2 ), percent-predicted peak VO 2 and oxygen uptake at anaerobic threshold (VO 2 -AT). Methods This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months. Results 76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO 2 in comparison to control (67 ± 17 to 73 ± 19%; p = 0.01). Additional primary endpoints peak VO 2 and VO 2 -AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively). Conclusion APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO 2 , an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life.

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“…Although a few interventions, such as nasal dilator strips [9], have been considered an attractive placebo, sham-CPAP has been advocated as a placebo that most closely mimics active therapy. Some studies have reported sham to be a useful placebo intervention based on the potential for blinding participants [10,11].…”

Section: Introductionmentioning

confidence: 99%

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

Reid

Gleason

Bakker

et al. 2019

Sleep

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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 NCT 01261390 Best Apnea Interventions for Research (BestAIR) www.clinicaltrials.gov

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Nasal Dilator Strip is an Effective Placebo Intervention for Severe Obstructive Sleep Apnea

Abstract: Our data indicate that NDS is an attractive placebo intervention for randomized controlled trials evaluating the effects of CPAP in sleepy patients with OSA.

Cited by 17 publications

References 39 publications

The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic

The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic

Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction

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

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