Table 1—

Randomised, placebo-controlled trials of medical and surgical therapies in sleep-disordered breathing

First author [ref.]Patient detailsInterventionDetails of interventionOutcomes#
Kiely 3923 subjects, 10 snorers and 13 OSA patients, all with chronic rhinitisDrug therapyIntranasal fluticasone versus saline placebo; double-blind, crossover designAHI and NAR decreased on fluticasone; no difference in sleep architecture, snoring and Sp,O2
Brouillette 4025 children with OSA and adenotonsillar hypertrophyDrug therapyIntranasal fluticasone versus placebo; triple-blind, parallel designAHI, Sp,O2 and arousal frequency improved on fluticasone; no change in symptoms
Pevernagie 4112 snorers with mean AHI 6 and chronic rhinitis with nasal obstructionMechanical deviceBreathe Right1TM versus placebo strips; double-blind, crossover designDecrease in snoring events, no change in AHI, arousal index or sleep architecture
Bahammam 4218 snorers with UARS, mean AHI 8.9Mechanical deviceBreathe Right1TM versus placebo strips; double-blind, crossover designImproved desaturation time and sleep architecture; no change in AHI, arousal index, or MSLT
Koutsourelakis 4349 patient with moderate-to-severe OSA and fixed nasal obstruction due to deviated septumSurgical therapyRandom assignment to septoplasty or sham surgeryNo change in AHI overall but pre-operative nasal breathing positively related to changes in AHI
  • The studies presented are limited to those involving a randomised, double-blind (for nonsurgical studies) and placebo-controlled design, with objective sleep studies and a minimum treatment period of 1 week. Breathe Right1TM manufactured by 3M, Borken, Germany. OSA: obstructive sleep apnoea; AHI: apnoea/hypopnoea index; NAR: nasal airflow resistance; Sp,O2: arterial oxygen saturation measured by pulse oximetry; UARS: upper airway resistance syndrome; MSLT: multiple sleep latency testing. #: p<0.05 considered to be statistically significant.