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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 communicate”
 
 
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.

 
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