Trial reportSleep & breathing = Schlaf & Atmung2009
The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease.
Trial report in Sleep & breathing = Schlaf & Atmung, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00316992 (A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 16 papers.
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.
A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Who cites it
16 citing papers in PubMed, 67 citations in OpenAlex.
- 2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults - Brazilian Sleep Association.Sleep science (Sao Paulo, Brazil) · 2023Review
- Serendipity.Sleep advances : a journal of the Sleep Research Society · 2023Article
- Benzodiazepine Prescribing in People with Chronic Obstructive Pulmonary Disease: Clinical Considerations.Drugs & aging · 2020Review
- Insomnia in Elderly Patients: Recommendations for Pharmacological Management.Drugs & aging · 2018Review
- Sleep in Chronic Obstructive Pulmonary Disease: Evidence Gaps and Challenges.Canadian respiratory journal · 2016Review
- New Developments in Insomnia Medications of Relevance to Mental Health Disorders.The Psychiatric clinics of North America · 2015Review
- Sleep disorders in chronic obstructive pulmonary disease: etiology, impact, and management.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2015Review
- Optimizing the Pharmacologic Treatment of Insomnia: Current Status and Future Horizons.Sleep medicine clinics · 2013Article
- Sleep disorders in COPD: the forgotten dimension.European respiratory review : an official journal of the European Respiratory Society · 2013Review
- Actigraphic assessment of sleep in chronic obstructive pulmonary disease.Sleep & breathing = Schlaf & Atmung · 2013Article
- Comorbid insomnia in sleep-related breathing disorders: an under-recognized association.Sleep & breathing = Schlaf & Atmung · 2012Review
- Critical appraisal of ramelteon in the treatment of insomnia.Nature and science of sleep · 2010Article
- Therapies for insomnia and comorbid chronic obstructive pulmonary disease with a focus on ramelteon (rozerem).P & T : a peer-reviewed journal for formulary management · 2009Article
- Review
- New approaches in the management of insomnia: weighing the advantages of prolonged-release melatonin and synthetic melatoninergic agonists.Neuropsychiatric disease and treatment · 2009Article
- Ramelteon: a review of its use in insomnia.Drugs · 2008Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIndividuals with moderate to severe chronic obstructive pulmonary disease (COPD) have poor sleep quality. This study evaluated the effects of ramelteon, an MT(1)/MT(2) melatonin receptor agonist indicated for insomnia treatment on respiration in this population. MATERIALS AND
methodsThis double-blind, crossover study enrolled 25 subjects (>or=40 years) with moderate to severe COPD (FEV(1)/FVC <70% and FEV(1) between 50 and 80% of predicted value [moderate], or FEV(1)/FVC <70% and FEV(1) <50% of predicted value [severe]). Subjects received ramelteon 8 mg or placebo for one night 30 min before polysomnographic monitoring, including measurement of oxygen saturation (SaO(2)) and respiratory effort and flow. Subjects crossed to alternate treatment after a 5- to 10-day washout. The primary endpoint was mean SaO(2) for the entire night.
resultsNo significant difference in SaO(2) for the entire night was observed with ramelteon vs placebo (92.2% vs 92.5%, P = 0.576). Mean SaO(2) was similar between ramelteon and placebo for each hour of the night, each sleep stage, the number of minutes that SaO(2) was <80% and <90%, and mean apnea-hypopnea index. There was a significant difference in total sleep time (389.0 vs 348.4 min, P = 0.019) and sleep efficiency (81.0 vs 72.6%, P = 0.019), and latency to persistent sleep was shorter (23.1 vs 56.9 min, P = 0.051), with ramelteon vs placebo. All adverse events were mild to moderate; none led to study discontinuation.
conclusionRamelteon did not produce respiratory depressant effects as measured by oxygenation or abnormal breathing events in subjects with moderate to severe COPD. Ramelteon was well tolerated in this population.
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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.