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The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure
Amaro, Aline C.S.; Duarte, Felipe H.G.; Jallad, Raquel S.; Bronstein, Marcello D.; Redline, Susan; Lorenzi-Filho, Geraldo.
  • Amaro, Aline C.S.; Universidade de São Paulo. Faculdade de Medicina. São Paulo. BR
  • Duarte, Felipe H.G.; Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. São Paulo. BR
  • Jallad, Raquel S.; Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. São Paulo. BR
  • Bronstein, Marcello D.; Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. São Paulo. BR
  • Redline, Susan; Brigham and Women's Hospital and Beth Israel Deaconess Medical Center. Harvard Medical School. Departments of Medicine. Boston. US
  • Lorenzi-Filho, Geraldo; Universidade de São Paulo. Faculdade de Medicina. São Paulo. BR
Clinics ; 67(5): 469-474, 2012. tab
Article in English | LILACS | ID: lil-626343
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 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

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.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Acromegaly / Sleep Apnea, Obstructive / Continuous Positive Airway Pressure / Dilatation / Nasal Cavity Type of study: Controlled clinical trial Limits: Adolescent / Adult / Aged / Female / Humans Language: English Journal: Clinics Journal subject: Medicine Year: 2012 Type: Article Affiliation country: Brazil / United States Institution/Affiliation country: Brigham and Women's Hospital and Beth Israel Deaconess Medical Center/US / Universidade de São Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Acromegaly / Sleep Apnea, Obstructive / Continuous Positive Airway Pressure / Dilatation / Nasal Cavity Type of study: Controlled clinical trial Limits: Adolescent / Adult / Aged / Female / Humans Language: English Journal: Clinics Journal subject: Medicine Year: 2012 Type: Article Affiliation country: Brazil / United States Institution/Affiliation country: Brigham and Women's Hospital and Beth Israel Deaconess Medical Center/US / Universidade de São Paulo/BR