Emsellem Helene A, Colwell Hilary H, Cronin John, Farkas Ronald H, Mathias Susan D
Sleep Health Institute, 10221 River Road, PO Box 61324, Potomac, MD, 20859, USA.
Health Outcomes Solutions, 1149 Crystal Drive, Palm Beach Gardens, FL, 33418, USA.
Health Qual Life Outcomes. 2025 Mar 24;23(1):26. doi: 10.1186/s12955-025-02355-1.
We sought to identify important issues regarding symptoms and impacts of obstructive sleep apnea (OSA), to explore fatigue and sleepiness, and evaluate the content, clarity, and relevance of specific patient reported outcome (PRO) measures.
Participants in the US with OSA and at least mild fatigue were studied. Individuals with positive airway pressure (PAP) therapy intolerance or current PAP refusal (non-PAP users) and those who initiated PAP within the past 12 months (PAP users) were identified and interviewed. Interviews included concept elicitation questions about symptoms and impacts of OSA. Participants then completed several PRO measures (the PRO Measurement Information System [PROMIS] Fatigue-8a, PROMIS Sleep-Related Impairment-8a, Epworth Sleepiness Scale [ESS], Patient-Global Impression of Severity of Fatigue [PGI-S Fatigue], and Patient Global Impression of Change in Fatigue [PGI-C Fatigue]) and were cognitively debriefed to evaluate their content, clarity, and relevance.
A total of 30 individuals with OSA (20 non-PAP and 10 PAP) were enrolled. In addition to fatigue (reported by 100%), sleepiness (75%), difficulty concentrating (85%), dry mouth/throat (60%), headaches (50%) and interrupted sleep (50%) were the most common symptoms reported by non-PAP users. Fifty-eight percent of non-PAP users rated fatigue as the most bothersome symptom; 5% rated sleepiness as the most bothersome. Among PAP users, the most common symptoms (prior to PAP use) in addition to fatigue (100%) were sleepiness (90%), difficulty concentrating (60%), dry mouth/throat (60%), headaches (50%), and interrupted sleep (50%). Fatigue was rated as most bothersome by 56% of PAP users; sleepiness was rated as the most bothersome by 22%. All participants mentioned fatigue and sleepiness separately, indicating they are considered distinct symptoms. In general, participants found the PRO measures to be relevant and clear, and results supported their content validity, clarity, and relevance.
Fatigue was the most bothersome symptom reported by non-PAP and PAP users. Participants described fatigue as a distinct and different concept from excessive daytime sleepiness. Participants reported that their OSA symptoms negatively impact daily activities, functioning, work, and relationships. The PRO measures are clear and relevant for individuals with OSA and appropriate for use in both clinical and research settings.
我们试图确定有关阻塞性睡眠呼吸暂停（OSA）症状及影响的重要问题，探究疲劳和嗜睡情况，并评估特定患者报告结局（PRO）指标的内容、清晰度和相关性。
对美国患有OSA且至少有轻度疲劳的参与者进行研究。确定并访谈了气道正压通气（PAP）治疗不耐受或当前拒绝使用PAP的个体（非PAP使用者）以及在过去12个月内开始使用PAP的个体（PAP使用者）。访谈包括关于OSA症状及影响的概念引出问题。参与者随后完成了几项PRO指标（PRO测量信息系统[PROMIS]疲劳-8a、PROMIS睡眠相关损害-8a、爱泼沃斯嗜睡量表[ESS]、患者疲劳严重程度整体印象[PGI-S疲劳]以及患者疲劳变化整体印象[PGI-C疲劳]），并接受认知性汇报以评估这些指标的内容、清晰度和相关性。
共招募了30名OSA患者（20名非PAP使用者和10名PAP使用者）。除疲劳（100%报告）外，非PAP使用者报告的最常见症状还有嗜睡（75%）、注意力难以集中（85%）、口干/咽干（60%）、头痛（50%）和睡眠中断（50%）。58%的非PAP使用者将疲劳评为最困扰的症状；5%将嗜睡评为最困扰的症状。在PAP使用者中，除疲劳（100%）外，使用PAP前最常见的症状还有嗜睡（90%）、注意力难以集中（60%）、口干/咽干（60%）、头痛（50%）和睡眠中断（50%）。56%的PAP使用者将疲劳评为最困扰的症状；22%将嗜睡评为最困扰的症状。所有参与者都分别提到了疲劳和嗜睡，表明它们被视为不同的症状。总体而言，参与者认为PRO指标相关且清晰，结果支持了其内容效度、清晰度和相关性。
疲劳是未使用PAP和使用PAP的患者报告的最困扰症状。参与者将疲劳描述为与白天过度嗜睡不同的概念。参与者报告称，他们的OSA症状对日常活动、功能、工作和人际关系产生负面影响。PRO指标对OSA患者清晰且相关，适用于临床和研究环境。
