The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure

Abstract

OBJECTIVES:The aim of the current study was to compare the objective and subjective effects of continuous positive airway pressure to the use of nasal dilator strips in patients with acromegaly and moderate to severe obstructive sleep apnea.METHODS:We studied 12 patients with acromegaly and moderate to severe obstructive sleep apnea (male/females = 8/4, age = 52±8 ys, body mass index = 33.5±4.6 Kg/m2, apnea–hypopnea index = 38±14 events/h) who had been included in a randomized, crossover study to receive three months of treatment with continuous positive airway pressure and nasal dilator strips. All patients were evaluated at study entry and at the end of each treatment by polysomnography, and Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and treatment satisfaction questionnaires. ClinicalTrials.gov: NCT01265121RESULTS:The apnea–hypopnea index values decreased significantly with continuous positive airway pressure treatment but did not change with the use of nasal dilator strips. All of the subjective symptoms improved with both treatments, but these improvements were significantly greater with continuous positive airway pressure than with the nasal dilator strips.CONCLUSION:The use of nasal dilator strips had a much smaller effect on the severity of obstructive sleep apnea in patients with acromegaly and moderate to severe obstructive sleep apnea in comparison to the use of continuous positive airway pressure. Moreover, the improvement in several subjective parameters without any significant objective improvement in obstructive sleep apnea resulting from the use of nasal dilator strips is compatible with a placebo effect.

Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment

“…All studies were RCTs, with 3 studies using a randomized, cross-over design. 61,65,84 Participants were randomized to CPAP or a control intervention. The control interventions utilized included sham CPAP (n = 5), 34,66,74,84,93 conservative measures (advice on weight loss or good sleep habit counseling), no intervention (n = 3), 78,82,92 sham surgery (n = 1), 90 placebo tablet (n = 1), 65 and nasal dilator strips (n = 1) 61 .…”

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

“…37 One previous study also suggested that NDS was an effective placebo intervention in a randomized crossover protocol evaluating 3 mo of treatment with CPAP in 12 patients with acromegaly and moderate to severe OSA. 23 Those authors found no effects of NDS on AHI compared with CPAP but an improvement of subjective parameters, which was compatible with a placebo effect. The current study showed that patients reported decreased diurnal sleepiness, and it also demonstrated reduced scores for the depression inventory after 1 mo of the NDS intervention compared with baseline.…”

Cognition and obstructive sleep apnoea in Parkinson’s disease, effect of positive airway pressure therapy (COPE-PAP trial): protocol of a randomized controlled trial

“…NDS is a form of placebo control to PAP and has been successfully used previously in RCTs. 24,25 A placebo effect was notable in that subjective sleep quality improved, without improvement in OSA parameters on PSG. NDS are safe, with minimal adverse reactions (skin irritation or localized allergic reaction).…”