Sleep Light Trial

A randomized, placebo-controlled trial of sleep induction with low-dose dexmedetomidine during the night on delirium occurrence and safety in non-intubated critically ill patients - Sleep Light Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051250090

Enrollment

354

Registered

2025-08-18

Start date

2025-10-07

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

Non-intubated critically ill patients, delirium delirium

Interventions

Dexmedetomidine: infusion of 0.2 mcg/kg/h from 19:00 to 6:00 the next day of day 1 to day 5 or discharge by day 5 during the stay at ICU/HDU.

Dexmedetomidine

dexmedetomidine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Non-intubated critically ill aged 65 and older patients who are urgently admitted to ICU/HDU

Exclusion criteria

Exclusion criteria: 1)Patients received dexmedetomidine within 1 week 2)Patients had participated in this trial before 3)Patients who will be discharged from the ICU or HDU the day after participation in the trial 4)Patients with tracheostomy 5)Difficult to communicate since before the illness 6)Glasgow coma scale (GCS) equal to less than 8 7)Bradycardia of heart rate less than 40/min and bradyarrhythmia without cardiac pacemaker 8)Body weight equal to more than100 kg 9)Patients who cannot understand Japanese 10)Patients who are judged by the principal investigator or sub investigator to be inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Delirium occurrence (incidence and prevalence) from 3 hours after investigational drug administration on day 1 to day 6	—

Secondary

Measure	Time frame
Hyperactive delirium occurrence from 3 hours after investigational drug administration on day 1 to day 6 Hypoactive delirium occurrence from day 2 to day 6 Mixed delirium occurrence from day 2 to day 6 Delirium-free days/proportion of delirium-free days during the participants stay in ICU/HDU Time to delirium resolution In-hospital mortality Tracheal intubation Each RASS score at 20, 22, 0, 3, and 6 oclock after the start of administration of the investigational drug Proportion of participants with a RASS score of between -3 and -1 at 20, 22, 0, 3, and 6 oclock after the start of administration of the investigational drug Each RASS score at 10, 14, and 18 oclock from day 2 to day 6 Proportions of unintentional diurnal sedation at 10, 14, and 18 oclock from day 2 to day 6 Proportions of use of other sedative drug during administration of investigational drug Proportions of other hypnotics as needed during administration of investigational drug Barthel Index Sequential organ failure assessment-2 score (SOFA-2) score SpO2/FiO2 ratio Platelet count Total bilirubin Mean arterial pressure GCS Acute kidney injury Newly onset tachyarrhythmia Newly onset atrial fibrillation Urine volume, Cre CRP Electroencephalography Costs (Total costs during admission) Final outcome (alive, dead, disposition) Duration of stay in ICU/HDU, and duration of the admission Safety Counterplan (e.g., restraint mittens, physical restraint) Dangerous behavior Contents of nursing care (time spent at the patient's bedside, number of phone calls to physicians, subjective fatigue and rest periods, and time of shift completion) Adverse events (oversedation, hypotension, bradycardia, withdrawal of dexmedetomidine, and so on)	—

Measure

Time frame

Hyperactive delirium occurrence from 3 hours after investigational drug administration on day 1 to day 6 Hypoactive delirium occurrence from day 2 to day 6 Mixed delirium occurrence from day 2 to day 6 Delirium-free days/proportion of delirium-free days during the participants stay in ICU/HDU Time to delirium resolution In-hospital mortality Tracheal intubation Each RASS score at 20, 22, 0, 3, and 6 oclock after the start of administration of the investigational drug Proportion of participants with a RASS score of between -3 and -1 at 20, 22, 0, 3, and 6 oclock after the start of administration of the investigational drug Each RASS score at 10, 14, and 18 oclock from day 2 to day 6 Proportions of unintentional diurnal sedation at 10, 14, and 18 oclock from day 2 to day 6 Proportions of use of other sedative drug during administration of investigational drug Proportions of other hypnotics as needed during administration of investigational drug Barthel Index Sequential organ failure assessment-2 score (SOFA-2) score SpO2/FiO2 ratio Platelet count Total bilirubin Mean arterial pressure GCS Acute kidney injury Newly onset tachyarrhythmia Newly onset atrial fibrillation Urine volume, Cre CRP Electroencephalography Costs (Total costs during admission) Final outcome (alive, dead, disposition) Duration of stay in ICU/HDU, and duration of the admission Safety Counterplan (e.g., restraint mittens, physical restraint) Dangerous behavior Contents of nursing care (time spent at the patient's bedside, number of phone calls to physicians, subjective fatigue and rest periods, and time of shift completion) Adverse events (oversedation, hypotension, bradycardia, withdrawal of dexmedetomidine, and so on)

—

Contacts

Public ContactTakuma Minami

Department of Primary Care and Emergency Medicine, Kyoto Univeristy Hospital

t.373@kuhp.kyoto-u.ac.jp+81-75-751-4210

Outcome results

None listed

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