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CTRI Number  CTRI/2025/10/096739 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation Between Patient and Family Completed Epworth Sleepiness Scale Scores with Obstructive Sleep Apnea Severity Based on Polysomnography 
Scientific Title of Study   Correlation Between Patient and Family Completed Epworth Sleepiness Scale Scores with Obstructive Sleep Apnea Severity Based on Polysomnography 
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 Ayushi Sinha 
Designation  DNB Resident 
Affiliation  Fortis Hospitals Limited 
Address  Departmen of Pulmonology and Critical Care

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9013888573  
Fax    
Email  sinhaayushi2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mrinal Sircar 
Designation  Director and Head of Department 
Affiliation  Fortis Hospitals Limited 
Address  Department of Pulmonology and Critical Care

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9871292226  
Fax    
Email  mrinal.sircar@fortishealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ayushi Sinha 
Designation  DNB Resident 
Affiliation  Fortis Hospitals Limited 
Address  Department of Pulmonology and Critical Care
B22, SECTOR 62, NOIDA, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9013888573  
Fax    
Email  sinhaayushi2015@gmail.com  
 
Source of Monetary or Material Support  
Fortis Hospital, B-22, Sector 62, Noida, Uttar Pradesh-201301 
 
Primary Sponsor  
Name  Fortis Hospitals Limited 
Address  B-22, SECTOR 62, NOIDA, UTTAR PRADESH-201301 
Type of Sponsor  Private hospital/clinic 
 
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 Ayushi Sinha  Fortis Hospital  Department of Pulmonology and Critical Care
Gautam Buddha Nagar
UTTAR PRADESH 
9013888573

sinhaayushi2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FORTIS HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients reporting symptoms suggestive of OSA, including but not limited to:

Loud snoring, witnessed apnoeas (breathing pauses during sleep), gasping or choking during sleep, excessive daytime sleepiness, morning headaches, unrefreshing sleep, fatigue, difficulty concentrating, irritability

PSG: Patients subjected to overnight diagnostic polysomnography (PSG) (home study or hospital-based study) within 4 weeks of being evaluated for inclusion in the study.

Family Member Availability: Patients who have a family member willing to participate in the study. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Family Reported ESS Correlating better with the OSA Severity (AHI) than patient reported ESS  7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Family Reported ESS Correlating better with PSG Parameters (ODI and Arousal Index) than Patient reported ESS  7 Days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   28/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  
Obstructive sleep apnoea (OSA) is a prevalent sleep disorder characterized by recurrent episodes of partial or complete upper airway collapse during sleep1. These events, known as apnoeas and hypopnoeas, lead to intermittent hypoxia and fragmented sleep. The prevalence of OSA varies globally, with estimates suggesting that it affects 936 million adults worldwide
OSA poses significant risks to overall health. Untreated OSA is associated with a heightened risk of cardiovascular diseases, such as hypertension, coronary artery disease, and stroke. Additionally, OSA can contribute to metabolic dysregulation, including insulin resistance and type 2 diabetes. Furthermore, OSA has been linked to cognitive impairment, mood disorders, and reduced quality of life.
Given the widespread prevalence and substantial health consequences of OSA, early diagnosis and appropriate treatment are paramount. Effective interventions, such as continuous positive airway pressure (CPAP) therapy, can significantly reduce OSA-related morbidity and mortality.
Excessive daytime sleepiness (EDS) is a hallmark symptom of obstructive sleep apnoea (OSA), often manifesting as difficulty maintaining alertness and an increased tendency to doze off during daily activities.
The Epworth Sleepiness Scale (ESS) is a widely used and validated tool for assessing daytime sleepiness. This self-administered questionnaire provides a standardized way to quantify the severity of EDS, aiding in the identification of individuals who may benefit from further evaluation for sleep disorders like OSA.
To definitively diagnose OSA and assess its severity, patients have to undergo polysomnography (PSG)
Key parameters measured during PSG include the apnoea-hypopnea index (AHI), oxygen desaturation index (ODI), and arousal index. The AHI, representing the average number of apnoeas and hypopneas per hour of sleep, is the primary measure used to classify OSA severity. A mild OSA diagnosis is given for an AHI of 5-14 events per hour, moderate OSA for 15-29 events per hour, and severe OSA for 30 or more events per hour. The ODI measures the frequency and magnitude of oxygen desaturation during sleep, while the arousal

index quantifies the number of brief awakenings caused by respiratory events. These additional parameters provide a more nuanced understanding of the impact of OSA on sleep quality and overall health.
Family members or spouse/partners of individuals with obstructive sleep apnoea (OSA) often play a crucial role in recognizing the signs and symptoms of the disorder. While patients may be unaware of their own snoring or apnoeic episodes during sleep, family members are frequently witness to these disturbances.
Previous studies have defined ‘partner’ as an individual who is either a spouse or cohabitating partner sharing the same living space. No Indian study is reported. Usual Indian families consist not only of the couples but also other adult family members. All family members can potentially provide valuable information about the frequency and severity of OSA symptoms, complementing the patient’s own self-reported ones and potentially aiding in early diagnosis.
Both patients and their family members can offer valuable perspectives on the presence and severity of excessive daytime sleepiness (EDS) in the context of obstructive sleep apnoea (OSA). However, research suggests that these perspectives may not always match each other. Some studies have found that ‘partners’ tend to report higher levels of sleepiness in OSA patients compared to the patients’ own self-assessment, while others have found no significant differences.
This study aims to investigate the association between both patient-reported and family-reported Epworth Sleepiness Scale (ESS) scores and the severity of obstructive sleep apnoea (OSA) as measured by the apnoea-hypopnea index (AHI) derived from polysomnography. By examining the correlations between these measures, we aim to assess the independent contribution of each perspective in identifying OSA and predicting its severity.
 
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