Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients

J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876.


Study objectives: Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.

Methods: Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.

Results: A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion (P = .186), rhinitis (P = .666), or snoring (P = .177). There was no difference in the pretreatment ESS score (P = .077), body mass index (P = .173), or AHI (P = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time (P = .02) and percent of stage R sleep (P = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores (P = .37-.46).

Conclusions: Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.

Clinical trial registration: Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.

Keywords: fluticasone; medical treatment; mild obstructive sleep apnea; montelukast; sleep quality.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / therapeutic use*
  • Administration, Intranasal
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluticasone / administration & dosage
  • Fluticasone / therapeutic use*
  • Humans
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Middle Aged
  • Prospective Studies
  • Quinolines / therapeutic use*
  • Sleep Apnea, Obstructive / drug therapy*
  • Treatment Outcome


  • Acetates
  • Anti-Inflammatory Agents
  • Leukotriene Antagonists
  • Quinolines
  • Fluticasone
  • montelukast

Associated data

  • ClinicalTrials.gov/NCT01089647