title: Nasal Dilator Strip is an Effective Placebo Intervention for Severe Obstructive Sleep Apnea.
abstract: OBJECTIVE
  The aim of this study was to evaluate the effects of nasal dilator strip (NDS) as a placebo intervention compared with continuous positive airway pressure (CPAP) treatment in patients with severe obstructive sleep apnea (OSA).
  
  
  METHODS
  Patients were treated with both NDS and nasal CPAP. The sequence was randomized and interposed by 15 days of washout. Polysomnography was performed at baseline and on the first night of intervention with NDS and CPAP (titration). The Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Beck Depression Inventory (BDI) were completed at baseline and at the end of both interventions. A questionnaire on the comfort and satisfaction (0 = no to 10 = total) was completed at the end of each intervention.
  
  
  RESULTS
  Twenty-six patients with OSA were evaluated (19 male; age 46.3 ± 9.3 y; body mass index 33.2 ± 5.1 kg/m2; ESS 15.8 ± 4.1; apnea-hypopnea index 60.7 ± 25.2). Adherence was high in both NDS (98%) and CPAP interventions (94%; 5.8 ± 1.7 h/night). In contrast to the baseline values, NDS intervention had no significant effect on all polysomnographic parameters, but NDS improved somnolence (ESS 13.0 ± 5.4, p = 0.001) and depressive symptoms (BDI 7.7 ± 6.9, p = 0.005). Reported satisfaction was significantly higher for CPAP than for NDS (sleep quality 9.2 ± 0.8 vs. 6.1 ± 2.1; wake up at morning: 8.6 ± 1.2 vs. 6.0 ± 2.2; daily activities: 8.9 ± 1.4 vs. 5.8 ± 1.5; quality of life: 8.3 ± 2.1 vs. 3.8 ± 3.5, p < 0.001), but similar low levels of difficulty for both interventions were observed (1.3 ± 2.2 vs. 0.3 ± 1.3, p = 0.098).
  
  
  CONCLUSIONS
  Our data indicate that NDS is an attractive placebo intervention for randomized controlled trials evaluating the effects of CPAP in sleepy patients with OSA.
authors.affiliation: Faculdade de Medicina da Universidade de São Paulo, Heart Institute (InCor), Pulmonary Division, Sleep Laboratory, São Paulo, Brazil.
authors.forename: Fabiana
authors.initials: F
authors.lastname: Yagihara
authors.affiliation: Faculdade de Medicina da Universidade de São Paulo, Heart Institute (InCor), Pulmonary Division, Sleep Laboratory, São Paulo, Brazil.|Núcleo Interdisciplinar da Ciência do Sono (NICS), São Paulo, Brazil.
authors.forename: Geraldo
authors.initials: G
authors.lastname: Lorenzi-Filho
authors.affiliation: Faculdade de Medicina da Universidade de São Paulo, Heart Institute (InCor), Pulmonary Division, Sleep Laboratory, São Paulo, Brazil.|Núcleo Interdisciplinar da Ciência do Sono (NICS), São Paulo, Brazil.
authors.forename: Rogerio
authors.initials: R
authors.lastname: Santos-Silva
mesh_terms: D001938:Brazil; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009666:Nose; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010919:Placebos; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D010919:Placebos
keywords: CPAP; nasal dilator strip; obstructive sleep apnea; placebo