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CTRI Number  CTRI/2024/09/073772 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Sleep assessment (outcome) in acute neurological ill patients with peripheral nervous system disorder - Guillain Barre syndrome (population) admitted to Intensive Care Unit (setting)  
Scientific Title of Study   Comprehensive Assessment of Night time sleep in Conscious Guillain Barré syndrome GBS patients in Intensive Care Unit ICU. A Prospective Observational Study 
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 Jhansi Eda 
Designation  DM Resident 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road Bangalore Karnataka 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9652717362  
Fax    
Email  jhansiraoeda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sriganesh K 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care, National INstitute of Mental Health and Neurosciences (NIMHANS), Hosur Road Bangalore Karnataka 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9481445949  
Fax    
Email  drsri23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sriganesh K 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road Bangalore Karnataka 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9481445949  
Fax    
Email  drsri23@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore Karnataka 560029 India 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences NIMHANS 
Address  Department of Neuroanaesthesia and Neurocritical Care, faculty building, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road Bangalore Karnataka 560029 India 
Type of Sponsor  Research institution and hospital 
 
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 Jhansi Eda  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES  Department of Neuroanaesthesia and Neurocritical care, Neuro intensive care unit, on the 2nd floor of neuro centre and emergency block
Bangalore
KARNATAKA 
9652717362

jhansiraoeda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G610||Guillain-Barre syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Conscious patients diagnosed with GBS admitted to ICU 
 
ExclusionCriteria 
Details  1. Refusal of consent to participate in the study
2. Patients with hearing deficits or psychiatric illness precluding assessment
3. Patients with known sleep disorders before ICU admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To comprehensively assess the burden of sleep disturbance using EEG in GBS patients admitted to the ICU   1. EEG assessment will be done on day 2 of ICU admission
2. EEG assessment will be done on day 5 of ICU admission
3. EEG assessment will be done on day of discharge from ICU  
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the quality & quantity of sleep assessed using EEG with sleep questionnaire
2. To evaluate the effect of night tine sleep disturbance on ICU delirium, weaning from ventilator & patient satisfaction
3. To assess the temporal sleep changes during ICU stay
4. To assess the impact of ICU environment like noise & sound on the quality & quantity of sleep
5. To assess the impact of disturbed sleep in ICU on long term sleep quality using a sleep questionnaire at 3 months after discharge from ICU 
Sleep questionnaire will be performed on day 2 of ICU admission
Sleep questionnaire will be performed on day 3 of ICU admission
Sleep questionnaire will be performed on day 5 of ICU admission
Sleep questionnaire will be performed on day 6 of ICU admission
Sleep questionnaire will be performed one day prior to discharge from ICU
Sleep questionnaire will be performed on the day of discharge from ICU
Sleep questionnaire will be performed at 3 months after discharge from ICU via phone call 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
Sleep is defined as a periodic, reversible state of disengagement and insensitivity from the environment. Although the sleep has a primary function of restorative process that aid in cognitive functioning, it also plays a pivotal role in metabolic conservation and produces an anabolic state. Sleep is a circadian phenomena. The most predominant factor that effect this cycle is light/dark cycle as melatonin, sleep promoting hormone is produced maximal at night. In the ICU setting disturbed sleep is multifactorial that can present with various adverse consequences, like cognitive impairment, depression, poor outcome, reduced host immunity, attenuated ventilatory response to hypoxemia and hypercapnia, increased carbon dioxide production. This in turn leads to difficulty in liberation from mechanical ventilation, and increased morbidity.  Around 30% of  GBS patients present with respiratory failure requiring ventilation and ICU admission. The mechanism of Sleep disturbance in GBS patients is attributed to involvement of lateral hypothalamus where blood-brain-barrier is exposed to antibodies, disruption in corollary discharge system, underlying stress and anxiety, proinflammatory cytokines causing neurotransmitter dysfunction, and autonomic dysfunction. Although disturbed sleep has adverse consequences, it is more recently it has taken place in ICU care and neuro-rehabilitation. There is limited data available on qualitative sleep assessment in GBS patients admitted to the ICU, we intend to conduct the study to assess the burden sleep disturbance in GBS patients, and identify the risk factors affecting the sleep during the ICU stay, and on long term sleep quality using EEG, and sleep questionnaire

 
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