Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke - Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012755

Enrollment

100

Registered

2014-01-04

Start date

2014-01-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

administration group:ramelteon 8mg, just before sleep, daily Non-administration group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients who were hospitalized for a stroke acute phase and experienced sleep disruption

Exclusion criteria

Exclusion criteria: 1.Patients taking ramelteon at the time of admission 2.Patients with contraindication for ramelteon (known hypersensitivity to remelteon, a history of severe liver/hepatic dysfunction, patients taking fluvoxamine maleate) 3.Patients who were not able to take drug both orally and through the tube

Design outcomes

Primary

Measure	Time frame
Richmond agitation sedation scale two weeks after intervention	—

Secondary

Measure	Time frame
sleep condition/ insomnia/ daytime somnolence/ administration of sedative medication, psychotropic medication and sleep medication except for ramelteon/ body restraint/ fall/ modified Rankin Scale/ adverse events	—

Countries

Japan

Contacts

Public ContactYuichi Kawabata

Yokohama Sakae Kyosai Hospital Department of Neurology and Stroke Medicine

y-kawabat@hotmail.co.jp045-891-2171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026