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临床试验/CTRI/2025/10/096739
CTRI/2025/10/096739尚未招募不适用

Correlation Between Patient and Family Completed Epworth Sleepiness Scale Scores with Obstructive Sleep Apnea Severity Based on Polysomnography

Fortis Hospitals Limited1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Family Reported ESS Correlating better with the OSA Severity (AHI) than patient reported ESS

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Family Reported ESS Correlating better with the OSA Severity (AHI) than patient reported ESS

时间窗: 7 Days

次要结局

  • Family Reported ESS Correlating better with PSG Parameters (ODI and Arousal Index) than Patient reported ESS(7 Days)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Ayushi Sinha

Fortis Hospitals Limited

研究点 (1)

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