The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure.
OBJECTIVE
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/m(2), 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: NCT01265121


RESULTS
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.


CONCLUSIONS
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.
Faculdade de Medicina, Universidade de São Paulo, Brazil.
Aline C S
AC
Amaro
Felipe H G
FH
Duarte
Raquel S
RS
Jallad
Marcello D
MD
Bronstein
Susan
S
Redline
Geraldo
G
Lorenzi-Filho
D000172:Acromegaly / Q000150:complications*; D000293:Adolescent; D000328:Adult; D000368:Aged; D045422:Continuous Positive Airway Pressure; D018592:Cross-Over Studies; D004106:Dilatation / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009296:Nasal Cavity; D015990:Placebo Effect; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D011795:Surveys and Questionnaires; D055815:Young Adult