Trial reportAnnals of the American Thoracic Society2016
Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.
Trial report in Annals of the American Thoracic Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05911646 (OSA-18 in Children With Mild Obstructive Sleep Apnea), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 127 citations in OpenAlex.
- Advancements in pediatric obstructive sleep apnea: cognitive implications and the role of AI in precision medicine.Frontiers in medicine · 2025Pooled it
- Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023Pooled it
- Anti-inflammatory medications for obstructive sleep apnoea in children.The Cochrane database of systematic reviews · 2020Pooled it
- Systemic corticosteroids could be used as bridge treatment in children with obstructive sleep apnea syndrome waiting for surgery.Sleep & breathing = Schlaf & Atmung · 2022Trial
- Pediatric OSA-Spectrum of the Disease and Opportunities for Personalized Interventions.Journal of personalized medicine · 2026Review
- Three Decades of Managing Pediatric Obstructive Sleep Apnea Syndrome: What's Old, What's New.Children (Basel, Switzerland) · 2025Review
- Intranasal Corticosteroids and Oral Montelukast for Paediatric Obstructive Sleep Apnoea: A Systematic Review.Pharmaceutics · 2025Review
- Risk and Protective Factors for Obstructive Sleep Apnea Syndrome Throughout Lifespan: From Pregnancy to Adolescence.Children (Basel, Switzerland) · 2025Review
- Respiratory and airway disorders in children with Down Syndrome: a review of the clinical challenges and management.Frontiers in pediatrics · 2025Review
- Effect of Combination Montelukast and Nasal Mometasone on Childhood Adenoid Hypertrophy.Iranian journal of otorhinolaryngology · 2024Article
- Diagnosis and Orthodontic Treatment of Obstructive Sleep Apnea Syndrome Children-A Systematic Review.Diagnostics (Basel, Switzerland) · 2024Review
- Medical Treatment of Obstructive Sleep Apnea in Children.Journal of clinical medicine · 2023Review
- The Role of Montelukast Sodium in Children with Adenoid Hypertrophy - A Comparative Study.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2023Article
- Adenotonsillectomy-related changes in systemic inflammation among children with obstructive sleep apnea.Journal of the Chinese Medical Association : JCMA · 2023Article
- Common sleep disorders in children: assessment and treatment.Neurosciences (Riyadh, Saudi Arabia) · 2023Review
- Personalized Medicine and Obstructive Sleep Apnea.Journal of personalized medicine · 2022Review
- Sex differences in the relationship of sleep-disordered breathing and asthma control among children with severe asthma.The Journal of asthma : official journal of the Association for the Care of Asthma · 2022Article
- Clinical and functional characteristics of OSA in children with comorbid asthma treated by leukotriene receptor antagonist: A descriptive study.Frontiers in neurology · 2022Article
- Efficacy of obstructive sleep apnea treatment by antileukotriene receptor and surgery therapy in children with adenotonsillar hypertrophy: A descriptive and cohort study.Frontiers in neurology · 2022Article
- Innovations in the Treatment of Pediatric Obstructive Sleep Apnea.Advances in experimental medicine and biology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
rationaleObstructive sleep apnea (OSA) is highly prevalent in children and is usually treated by adenotonsillectomy. Nonsurgical therapies for OSA consist primarily of antiinflammatory approaches and have gained popularity, but their efficacy remains to be critically examined.
objectivesTo determine the effect of montelukast on pediatric OSA.
methodsA prospective randomized double-blind controlled trial of polysomnographically diagnosed OSA in children ages 2-10 years who were treated with either oral montelukast (4 or 5 mg daily) or placebo for 16 weeks. Adherence to the medication was ascertained using automated timed pill dispensers along with weekly telephonic reminders. MEASUREMENTS AND MAIN
resultsNinety-two children diagnosed with OSA were approached, and 64 (69.6%) agreed to participate. Of these, 57 (89.0%) completed the 16-week trial, 28 in the montelukast group and 29 in the placebo group. Age, sex, and percentage of obesity were similar in the two groups, as were initial apnea-hypopnea index (AHI) scores. Overall, intention-to-treat analyses revealed that beneficial effects occurred in 20 children receiving montelukast (71.4%), whereas only 2 (6.9%) of the children receiving placebo showed reductions in AHI score (P < 0.001). Indeed, AHI decreased from 9.2 ± 4.1/hour total sleep time (TST) to 4.2 ± 2.8/hour TST (P < 0.0001) in montelukast-treated children, whereas in children receiving placebo, the AHI did not change (from 8.2 ± 5.0/h TST before to 8.7 ± 4.9/h TST at completion of the trial).
conclusionsWhen compared with placebo, montelukast for 16 weeks effectively reduced the severity of obstructive sleep apnea in children 2-10 years of age. These results support a therapeutic role for leukotriene modifiers in pediatric OSA provided that long-term trials confirm current findings. Clinical trial registered with www.clinicaltrials.gov (NCT 00599534).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.