| CTRI Number |
CTRI/2025/03/082347 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The effectiveness of sleep-wake cycle regulating agents in mitigating altered sensorium and promoting recovery in acutely ill patients receiving intensive care |
|
Scientific Title of Study
|
Navigating sensorium: Lemborexant vs. melatonin vs. placebo for management of delirium – a hospital-based, single-center, parallel, double blinded, randomized controlled trial |
| Trial Acronym |
SENTINEL-D |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Rikhari |
| Designation |
Assistant Professor (Psychiatry) |
| Affiliation |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun |
| Address |
Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9627951368 |
| Fax |
|
| Email |
praveenrikhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Rikhari |
| Designation |
Assistant Professor (Psychiatry) |
| Affiliation |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun |
| Address |
Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9627951368 |
| Fax |
|
| Email |
praveenrikhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Rikhari |
| Designation |
Assistant Professor (Psychiatry) |
| Affiliation |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun |
| Address |
Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun
Dehradun
UTTARANCHAL
248016
India |
| Phone |
9627951368 |
| Fax |
|
| Email |
praveenrikhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Rama Himalayan University, Jollygrant, Dehradun |
|
|
Primary Sponsor
|
| Name |
Praveen Rikhari |
| Address |
Assistant Professor, Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun |
| Type of Sponsor |
Other [Individual - Prinicipal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Praveen Rikhari |
Himalayan Institute of Medical Sciences |
Department of Psychiatry, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jollygrant, Dehradun
Dehradun
UTTARANCHAL |
9627951368
praveenrikhari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lemborexant |
5-10 milligram OD for 7 days |
| Intervention |
Melatonin |
5-10 milligram OD for 7 days
|
| Comparator Agent |
Placebo |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who will be diagnosed with delirium according to ICD-11
2. Those whose primary caregivers will provide written informed consent |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Memorial Delirium Assessment Scale Score |
4th Day, 8th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause mortality |
4th Day, 8th Day |
| Time to recovery from delirium |
4th Day, 8th Day |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [praveenrikhari@gmail.com].
- For how long will this data be available start date provided 20-02-2025 and end date provided 20-02-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will be a prospective, hospital-based, placebo-controlled, double- blind, three-arm, parallel randomized control trial. All the participants with delirium will be screened and those meeting the preset inclusion and exclusion criteria will be included in the study. Sociodemographic information, clinical data, and scores on the Memorial Delirium Assessment Scale (MDAS), Charlson Comorbidity Index (CCI), and Anticholinergic Burden Score (ABC) will be collected at baseline. After randomisation patient will be assigned to either Group A (lemborexant) or Group B (melatonin) or Group C (placebo group). The starting dose for both lemborexant and melatonin at baseline would be one oral tablet of 5mg. Similarly, patients receiving placebo will be given one tablet initially. All subjects will be continuously monitored. Relevant clinical data and scores on the MDAS, CCI and ABC will be recollected on the 4th day and 8th day from baseline. In those with persistent delirium on the 4th day, the dose will be increased to 2 tablets or 10mg of either drug. Similarly, in patients receiving placebo dose will be increased to 2 tablets. A record of any adverse events will be maintained throughout the study period. The primary outcome measure of this study will be the change in MDAS scores from baseline to the 4th and 8th days. The secondary outcome measures of this study will be all cause mortality by the 8th day, and length of delirium. |