Evidence map›Paper›PMID 17294232›Full record

Trial reportSleep & breathing = Schlaf & Atmung2007

Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea.

Meir Kryger, Sherry Wang-Weigand, Thomas Roth

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00672061 (A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Obstructive Sleep Apnea), which is not on this map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00672061 phase2completednot on this map

A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Obstructive Sleep Apnea

TypeinterventionalSponsorTakedaRan2003 to 2003Enrolled26ConditionsSleep Apnea, ObstructiveArmsRamelteon or Placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. Hypnotics on Obstructive Sleep Apnea Severity and Endotypes: A Systematic Review and Meta-Analysis.American journal of respiratory and critical care medicine · 2024
    Pooled it
  3. Drug therapy for obstructive sleep apnoea in adults.The Cochrane database of systematic reviews · 2013
    Pooled it
  4. A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Trial
  5. Trial
  6. Trial
  7. Effects of Suvorexant, an Orexin Receptor Antagonist, on Respiration during Sleep In Patients with Obstructive Sleep Apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016
    Trial
  8. Trial
  9. Effectiveness of ramelteon for insomnia symptoms in older adults with obstructive sleep apnea: a randomized placebo-controlled pilot study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010
    Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Serendipity.Sleep advances : a journal of the Sleep Research Society · 2023
    Article
  19. Article
  20. Comorbid Insomnia and Obstructive Sleep Apnea (COMISA): Current Concepts of Patient Management.International journal of environmental research and public health · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 2 countries.

Meir KrygerGaylord Hospital, Sleep Research and Education, 400 Gaylord Farm Road, Wallingford, CT 06492, USA.
Sherry Wang-Weigand
Thomas Roth
Gaylord Hospital · USHenry Ford Hospital · USTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ramelteon is a selective MT(1)/MT(2)-receptor agonist indicated for insomnia treatment. Because it has no depressant effects on the nervous system, it is not expected to affect the control of breathing. The potential effects of ramelteon on apneic and hypopneic events and arterial oxygen saturation (SaO(2)) in individuals with obstructive sleep apnea were assessed. In this double-blind, randomized, crossover study, 26 adults with mild to moderate obstructive sleep apnea received ramelteon 16 mg and placebo for one night each, with a 5- to 12-day washout period between treatments. Treatments were administered 30 min before habitual bedtime. Respiratory effort was monitored using respiratory inductance plethysmography, SaO(2) was measured by pulse oximetry, and sleep onset and duration were measured by polysomnography and post-sleep questionnaire. Post-sleep questionnaire also measured next-day residual effects. The primary measure was apnea-hypopnea index. Apnea-hypopnea index was similar in ramelteon and placebo groups (11.4 vs 11.1, respectively; CI = -2.1, 2.6, P = 0.812). Ramelteon had no effect on the number of central, obstructive, or mixed apnea episodes. No significant differences were observed in SaO(2) for the entire night between ramelteon and placebo (95.1 vs 94.7%; P = 0.070). Ramelteon did not meaningfully affect sleep when evaluated by polysomnography and post-sleep questionnaire. Compared with placebo, ramelteon had no significant effect on next-day residual effects. Adverse events were reported by three subjects in the ramelteon group: headache (n = 2) and urinary tract infection (n = 1). No adverse events were reported with placebo. Ramelteon was well-tolerated and, as expected, did not worsen sleep apnea when administered to subjects with mild to moderate obstructive sleep apnea.

Indexed as

AdultArousalDouble-Blind MethodFemaleHumansHypnotics and SedativesIndenesMaleMiddle AgedOxygenPolysomnographySleep Apnea, ObstructiveSleep Initiation and Maintenance DisordersSleep StagesWakefulnessHypnotics and SedativesIndenesOxygenramelteon

Identifiers

PMID17294232
OpenAlexW2040705431

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.