| CTRI Number |
CTRI/2024/09/074154 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of sleep enhancing methods in ICU patients |
|
Scientific Title of Study
|
Effectiveness of Combination of Oral Melatonin with Non-Pharmacological Measures vs Non-Pharmacological measures alone on Quality of Sleep in critically ill Adult patients- Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JeevaKumar R |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of anesthesia, Level 1, Aiims bhubaneswar, Sijua, patrapada Sijua, patrapada, bhubaneswar, orissa Khordha ORISSA 751019 India |
| Phone |
9840730725 |
| Fax |
|
| Email |
jeevaswimming@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Anesthesia office, 1st floor, AIIMS bhubaneswar, sijua, patrapada Sijua, patrapada, bhubaneswar, orissa Khordha ORISSA 751019 India |
| Phone |
9438884160 |
| Fax |
|
| Email |
anaes_alok@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Anesthesia office, 1st floor, AIIMS bhubaneswar, sijua, patrapada Sijua, patrapada, bhubaneswar, orissa Khordha ORISSA 751019 India |
| Phone |
9438884160 |
| Fax |
|
| Email |
anaes_alok@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS BHUBANESWAR, department of anesthesia, level 1, sijua, patrapada, bhubaneswar 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS BHUBANESWAR |
| Address |
Sijua, patrapada, bhubaneswar, orissa |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Jeevakumar |
All India Institute of medical sciences, BHUBANESWAR |
Central icu, surgical icu, Level 3, department of anesthesiology and critical care, sijua, patrapada, bhubaneswar, 751019 Khordha ORISSA |
9840730725
jeevaswimming@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP C Placebo |
non-pharmacological measures like eye mask, ear plugs, ventilator to assist control in the night, decreased nursing care interventions
Dose: placebo tablet hs
Route oral/rt
Duration: till death or discharge from icu or 14days of icu stay |
| Intervention |
GROUP I tablet melatonin 5mg hs |
Oral melatonin 5mg hs + non-pharmacological measures like eye mask, ear plugs, ventilator to assist control in the night, decreased nursing care interventions
Dose: melatonin tablet 5mg hs
Route oral/rt
Duration: till death or discharge from icu or 14days of icu stay |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients who are expected to stay for more than 48hrs in ICU and ability to understand and communicate and able to receive their medications orally or through a nasogastric tube during the ICU stay |
|
| ExclusionCriteria |
| Details |
Renal failure (dialysis dependence), Liver failure (Child-Pugh class C), Patients who don’t have the ability to understand and communicateâ€
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the difference in the quality of sleep in patients receiving oral melatonin 5mg along with non-pharmacological measures versus those receiving non pharmacological measures alone as measured by the mean Richards-Campbell Sleep Questionnaire score |
ICU admission to discharge or death or 14days of ICU stay whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean ICU length of stay |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mean difference in number of good sleep days using RCSQ score |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mean sleep hours measured with Actigraphy |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mean Cortisol level measured at 8AM (Alternate day) |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Incidence of delirium using CAM-ICU-7 Score |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mean patient ventilator days |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Re-intubation rates |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mean consumption of Sedatives |
ICU admission to 14 days of ICU stay or till discharge or till death |
| Mortality |
ICU admission to 14 days of ICU stay or till discharge or till death |
|
|
Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sleep disturbances are common in the ICU
and are associated with worse outcomes like delirium, anxiety, pain, prolonged
weaning, increased length of stay, and mortality. Although several factors like
disease-related, procedure-related and environment- related have been associated with sleep
disturbances in ICU patients; no recommendation has yet been made on improving
sleep and restoring circadian rhythm. Studies have evaluated the effect of
non-pharmacological and pharmacological interventions in the ICU and they
suggest that certain modifications may improve sleep in critically ill
patients. However, these studies have been conducted in specialized ICU
settings and in western populations, evaluating only isolated interventions and
or multifaceted interventions. Further, it is still being inconclusive whether
these proposed benefits can be replicated in a randomized controlled trial or
would translate to Indian settings.
The current study will
evaluate the impact in the quality of sleep with non-pharmacological measures
along with or without pharmacological measures (melatonin) in critically ill patients and
if there is any significant improvement in sleep outcomes with both the
measures or either of the measures, this can help in framing a protocol for
improving the quality of sleep in critically ill adult patients as well as
decreasing the incidence of delirium, length of stay, pain, anxiety, weaning
difficulties and mortality. |