ArticleJournal of pharmaceutical health care and sciences2024
Effect of melatonin on insomnia and daytime sleepiness, in patients with obstructive sleep apnea and insomnia (COMISA): A randomized double-blinded placebo-controlled trial.
Article in Journal of pharmaceutical health care and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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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.
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Who cites it
7 citing papers in PubMed.
- Effect of diamine oxidase (DAO) enzyme dietary supplementation in subjects with insomnia symptoms and single nucleotide polymorphisms of theSleep medicine: X · 2026Article
- Positive Airway Pressure Therapy and Health Care Resource Use in Patients With OSA and Comorbid Insomnia.Chest · 2026Article
- Comorbid Insomnia and Sleep Apnea Mechanistic Convergence, Phenotypic Heterogeneity, and Clinical Implications.Current sleep medicine reports · 2026Article
- The Hidden Burden of COMISA: Clinical Implications and Treatment Challenges.Pulmonary therapy · 2026Review
- Detailed Review of Melatonin and its Role in Managing the Symptoms of Depression.Current molecular medicine · 2026Review
- Responsiveness of ThymoDreamFrontiers in sleep · 2026Article
- The Recurrence of Venous Thromboembolism in Obstructive Sleep Apnea: A Narrative Review.Canadian respiratory journal · 2025Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCOMISA is a common disorder that results in nighttime awakenings ,daytime sleepiness and PAP intolerance. Cognitive behavioral therapy for insomnia is used to improve PAP adherence and no medication has been evaluated in such population yet. Melatonin with its chronobiotic and antioxidant effects may have potential benefits on COMISA consequences at the appropriate dose and time. This study aimed to evaluate the effect of melatonin on sleep quality, daytime sleepiness and PAP Compliance in patients with COMISA.
methodsThis double-blind placebo trial randomly assigned eligible OSA patients who suffered from insomnia despite using PAP for over a month to receive either melatonin 10 mg or placebo. The primary outcomes were measured by changes in the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ-10) over one month. Adherence to PAP was measured by the results of the PAP device reports on the average length of time and number of nights that the device was used.
resultsThirty patients were enrolled in the study after randomization. The melatonin arm showed significant improvement in all four primary outcomes compared to the placebo arm. The PSQI score was 3.836±1.839 in the melatonin arm versus 10.522±3.626 in the placebo arm (Pvalue<0.001). The ISI score was 8.476±3.568 in the melatonin arm versus 14.47±4.50 in the placebo arm (Pvalue<0.001). The ESS score was 6.854±4.334 in the melatonin arm versus 13.298±5.119 in the placebo arm (Pvalue<0.001). The FOSQ-10 score was 24.93±5.02 in the melatonin arm versus 19.87±4.24 in the placebo arm (Pvalue= 0.006). Additionally, nighttime consequences such as sleep latency and awakenings showed significant improvement in the melatonin arm. PAP devices results revealed improvement in duration of PAP use overnight.
conclusionsAdministering melatonin has been shown to improve self-reported sleep quality and PAP adherence in patients with COMISA.
trial registrationRegistration number IRCT20220105053635N1 was issued by the Iranian Registry of Clinical Trials (IRCT).
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