| CTRI Number |
CTRI/2025/11/097665 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the patterns of sleep disturbances in patients admitted to ICU using polysomnography machine |
|
Scientific Title of Study
|
Prevalence and patterns of sleep disturbances in neurocritical care patients assessed by Polysomnography-: A pilot 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 |
Jithu Mohan P |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical care
NIMHANS
Hosur Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9633226411 |
| Fax |
|
| Email |
jithumohanp007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohini M Surve |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical care
NIMHANS
Hosur Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9620216654 |
| Fax |
|
| Email |
rohinigondhule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohini M Surve |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical care
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9620216654 |
| Fax |
|
| Email |
rohinigondhule@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
Hosur Road
Bangalore
Karnataka
India
560029 |
| Type of Sponsor |
Government medical college |
|
|
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 Rohini M Surve |
NIMHANS |
Emergency ICU
2nd floor Emergency Block, NIMHANS
Hosur Road
Bangalore
560029
Bangalore
KARNATAKA |
9620216654
rohinigondhule@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, (2) ICD-10 Condition: G700||Myasthenia gravis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to ICU with Guillain Barre Syndrome or Myasthenia Gravis who are conscious and oriented.
|
|
| ExclusionCriteria |
| Details |
Patients who are sedated and ventilated.
Patients with a known history of hearing deficits, seizure disorder, intellectual disability, and psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the prevalence of sleep deprivation (total sleep time less than 7 hours with Arousal index more than 20 per hour).
To determine patterns of sleep disturbances such as changes in sleep stages (N1, N2, N3, REM), wakefulness after sleep
onset (WASO), sleep efficiency, sleep onset latency, day time sleep, total sleep (consist of any sleep stages) in 16-24h.
|
Day 2 of ICU admission for 16-24 hours
Day 5-7 of ICU admission for 16-24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess subjective sleep quality using Richard Campbell Sleep Questionnaire (RCSQ).
To compare objective polysomnography (PSG) findings with subjective questionnaire
responses.
To assess the temporal change in the sleep patterns over time.
Association of sleep patterns with pain (VAS scores) & ICU delirium (CAM ICU scores).
To understand micro-sleep architecture patterns (i.e., EEG spectral patterns, spindle parameters, slow wave parameters, slow-wave-spindle coupling & REM pattern analysis.
|
Day 1-7 of ICU admission |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/12/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This is a prospective observational study including patients admitted to Neuro-ICUs diagnosed with GBS and Myasthenia gravis and are conscious. This study will be conducted over 6 months after Institutional Ethics Board approval. All GBS and Myasthenia gravis patients admitted to Neuro-ICUs will be screened with inclusion and exclusion criteria. Patients will receive standard care provided by the ICU physician in charge. APACHE II score at the time of ICU admission, pre-existing sleep disturbances over a preceding 1-month period will be assessed using self-rated questionnaire of Pittsburgh Sleep Quality Index (PSQI) which will be answered by the next of kin. After taking the informed consent, patient will be briefed about the Richard Campbell Sleep Questionnaire. It is a 5 item self-report questionnaire. It has a Visual Analog Scale (VAS) ranging from 0 – 100 mm, with higher scores representing better sleep. The data is collected from the patient in the afternoon and total score, which is the mean of all 5 variables will be taken to assess the perception of sleep. The same day we do the comprehensive sleep analysis with Polysomnography. Polysomnography includes recording of Electroencephalogram (EEG), Electrooculogram (EOG), Electromyogram (EMG), Electrocardiogram (ECG), Respiratory efforts, Pulse oximetry, Snoring sounds. For EEG recording, EEG cup electrodes will be attached to the scalp with the help of adhesive glue and secured with a roller gauze wrapped around the head. Sleep EEG recording is done according to the American Academy of Sleep Medicine (AASM) criteria. The AASM recommends the following derivation- F4-M1, C4-M1, and O2-M1, F3-M2, C3-M2, and O1-M2. 1st polysomnography study : on day 2 of ICU admission for 16-24 hours 2nd polysomnography study: at 5-7 days of ICU admission for 16-24 hours |