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The effectiveness of sleep-wake cycle regulating agents in mitigating altered sensorium and promoting recovery in acutely ill patients receiving intensive care

Navigating sensorium: Lemborexant vs. melatonin vs. placebo for management of delirium a hospital-based, single-center, parallel, double blinded, randomized controlled trial - SENTINEL-D

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082347
Enrollment
117
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: F05- Delirium due to known physiological condition

Interventions

Intervention1: Melatonin: 5-10 milligram OD for 7 days Intervention2: Lemborexant: 5-10 milligram OD for 7 days Control Intervention1: Placebo: Not applicable

Sponsors

Praveen Rikhari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Those who will be diagnosed with delirium according to ICD-11 2. Those whose primary caregivers will provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Substance withdrawal delirium 2. Postictal confusion/state 3. Patients who will be comatose 4. Intubated patients/Patients on complete mechanical ventilatory support 5. Those with severe hepatic impairment (Child-Pugh Class C) 6. Those scheduled for surgery 7. Patients who will be unable to take oral drugs

Design outcomes

Primary

MeasureTime frame
Memorial Delirium Assessment Scale ScoreTimepoint: 4th Day, 8th Day

Secondary

MeasureTime frame
All cause mortalityTimepoint: 4th Day, 8th Day;Time to recovery from deliriumTimepoint: 4th Day, 8th Day

Countries

India

Contacts

Public ContactPraveen Rikhari

Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun

praveenrikhari@gmail.com9627951368

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026