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CTRI Number  CTRI/2024/02/062555 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How feeling sleepy during the day is related to ability to do things and overall tiredness in people with a condition called obstructive sleep apnea 
Scientific Title of Study   Correlation of daytime sleepiness with functional capacity and fatigue in obstructive sleep apnea patients 
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 Hetal Mistry  
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24,Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hetal Mistry  
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Razia begum jamil ahmed Shaikh 
Designation  Post Graduate Student  
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai-400008
OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai-400008
Mumbai
MAHARASHTRA
400008
India 
Phone  8591501339  
Fax    
Email  shaikhraziya10@gmail.com  
 
Source of Monetary or Material Support  
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Hetal Mistry  B.Y.L. Nair Charitable Hospital.  Pulmonary Medicine OPD, 2nd floor, OPD Building, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA 
9892971248

hetalmistry1975@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic committee T. N. Medical College and BYL Nair Ch. Hospital.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G473||Sleep apnea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed with obstructive sleep apnea
AHI Score more than 5 events per hours from Pulmonary medicine department 
 
ExclusionCriteria 
Details  1 Dyspnea at rest grade 4 according to modified medical research council grading.
2 Patients on continous positive airway pressure
3 Those with major respiratory, musculoskeletal or neurological Comorbity.
4 Systolic blood pressure more than 180 mmhg
5 Resting DBP more than 100 mmhg
6 Resting HR more than 120 bpm
7 Assistive aids for walking
8 Major audio-visual impairment
9 Patients unable to understand and follow the verbal commands
10 Not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Epworth sleepiness scale (ESS).
2.Six-minute walk test(6MWT).
3.Fatigue severity scale(FSS). 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 16/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Obstructive Sleep Apnea (OSA) has been recognised as a major cause of morbidity and mortality in developing countries like India. It is characterised by repeated episode of partial (hypopnea) or complete (apnea) upper airway obstruction during sleep that lead to snoring, frequent episode of sleep interruption, hypoxemia, hypercapnia, swing in intrathoracic pressure and increased sympathetic activity. Excessive Daytime Sleepiness (EDS) is prominent symptom of Obstructive Sleep Apnea (OSA) and which is measured by Epworth sleepiness scale (ESS). Functional capacity is an important dimension in human functioning. The six- minute walk test is easier to administer, better tolerable and more representative of activities of daily living than any other walking test. Fatigue is primarily a subjective experience that includes physiological performance decrements and psychological impairments such as decreased morale, judgement and mood. Perception of fatigue measured by the Fatigue Severity Scale (FSS).

The Aim of our study was to find the correlation of epworth sleepiness scale with functional capacity and fatigue in obstructive sleep apnea patients.

It was a cross-sectional, observational, correlation study of 50 OSA patients. They were enrolled after fullfiled the inclusion criteria and were willing to participate in study. After obtaining the written consent, the participants were administrated epworth sleepiness scale, fatigue severity scale and made to perform six-minute walk test in pulmonary medicine Out Patient Department at tertiary health care hospital. The time required was 30-35 minutes.

Data was collected and analysed for normality by shapiro-wilk test. Since, the epworth sleepiness scale and fatigue severity scale are likert scale, Spearman’s rho correlation was done to find the correlation of epworth sleepiness scale with functional capacity and fatigue severity scale in obstructive sleep apnea patients.


It was observed that there is significant moderate negative correlation between Epworth Sleepiness Scale (ESS) and percentage predicted value of 6MWT (Functional Capacity) with r value of -0.597 and p value of 0.001. Also, a significant moderate positive correlation between Epworth Sleepiness Scale (ESS) and Fatigue Severity Scale (FSS) with r value of 0.492 and p value of 0.001 was observed. Thus, the alternate hypothesis was proved to be corrected.


 
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