| 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
|
|
|
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
|
|
|
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
|