Improved Patient Reported Outcomes (iPRO) -Sleep Diary: A Tool to Improve Sleep Assessment in Clinical Trials

改善患者报告结果 (iPRO) - 睡眠日记：改善临床试验中睡眠评估的工具

• 批准号: 10599502
• 负责人: Justin Brooks
• 金额: $ 29.19万
• 依托单位: D-PRIME LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599502
• 关键词: Address; Agreement; Algorithms; Beds; Behavior; Clinical; Clinical Trials; Collection; Data; Data Aggregation; Data Reporting; Development; Devices; Diagnostic; Disease; Economic Burden; Ensure; Error Sources; Feedback; Freedom; Health; Individual; Intervention; Interview; Measurement; Measures; Mental Health; Methods; Modification; Moods; Online Systems; Outcome; Patient Education; Patient Outcomes Assessments; Patient Self-Report; Patients; Phase; Phase II Clinical Trials; Pilot Projects; Population; Program Appropriateness; Program Development; Qualifying; Quality of life; Randomized; Reporting; Self Assessment; Self Perception; Signal Transduction; Sleep; Sleep Disorders; Sleeplessness; Small Business Innovation Research Grant; Source; Structure; Symptoms; System; Therapeutic; Time; Treatment Efficacy; Unconscious State; clinical development; clinical outcome assessment; clinical practice; commercialization; comorbidity; contextual factors; design; diaries; drug development; economic impact; effective therapy; efficacy evaluation; experience; feasibility testing; improved; improvement on sleep; interest; meetings; novel; novel therapeutics; operation; patient retention; physical conditioning; preservation; primary outcome; programs; prototype; response; sensor; signal processing; sleep onset; technology platform; theories; therapeutic development; therapeutically effective; tool; tool development; treatment group; wearable device

Abstract Insomnia is a highly prevalent condition that significantly degrades the quality of life and health of millions of patients. By diagnostic definition, insomnia is a disease characterized by self-reported subjective criteria, thus therapeutic developers targeting insomnia typically evaluate their treatment’s efficacy based on patient reported outcomes in the form of sleep diaries. A critical flaw with this assessment approach is that self-perception of sleep is inherently noisy due to the inability of patients to perceive the transition to and from unconscious sleep and sources of variability related to bias, mood, and other contextual factors. To overcome this limitation, many clinical trials incorporate clinically validated wearable devices into their trials as surrogate assessments which are interpreted in conjunction with sleep diary data. Wearable devices are also imperfect tools to assess sleep because they are similarly limited by non-disease, non-treatment related factors including imperfect operation, imperfect algorithms, and misuse. Furthermore, numerous studies in clinical and non-clinical populations have demonstrated that there are significant discrepancies between sleep diaries and wearable device derived sleep metrics raising the question as to which assessment approach is valid. Without a method to reconcile differences between sleep diaries and wearable devices the current practice for clinical trials is to rely on sleep diary data which is suboptimal and may contribute to blunted or nonsignificant effects in trials. The improved patient reported outcome (iPRO) – Sleep Diary is a method and system designed to improve sleep assessment by combining sleep diary and wearable device data while maintaining the subjectivity of sleep assessment. The proposed solution is to provide patients their wearable device-derived sleep data contemporaneously with the completion of the sleep diary. The patient reported sleep diary measurement is still the outcome of interest, however patients have the freedom to incorporate or disregard their objective data in their assessment. This approach is inspired by signal processing theory where measurements from two sensors with uncorrelated sources of error (sleep diary and wearable device) are combined to improve the measurement of the underlying signal. The approach of providing patients their objective data and then using their sleep diary response (in contrast to averaging) is used to preserve patient autonomy and leverage the benefits of self-reported data. Preliminary data suggest the iPRO-Sleep Diary non-linearly improves measurement precision of sleep metrics and reduces discrepancy between device and sleep diary data. This platform technology is expected to improve the assessment of sleep in clinical trials and enable more efficient development of effective therapeutics.

抽象的 失眠是一种非常普遍的状况，可显着降低数百万的生活质量和健康状况 患者。根据诊断定义，失眠是一种以自我报告的主观标准为特征的疾病，因此 针对失眠的治疗开发人员通常会根据患者报告的治疗效果评估 以睡眠日记的形式结局。这种评估方法的关键缺陷是对 由于患者无法感知往返于无意识的睡眠的过渡，因此睡眠本质上是噪音 以及与偏见，情绪和其他上下文因素有关的可变性来源。为了克服这一限制，许多 临床试验将经过临床验证的可穿戴设备纳入其试验，作为代理评估 与睡眠日记数据一起解释。可穿戴设备也是评估睡眠的不完美工具 因为它们同样受到非疾病的限制，所以与未治疗相关的因素，包括不完美的操作，所以 不完美的算法和滥用。此外，关于临床和非临床人群的大量研究具有 证明睡眠日记与可穿戴设备衍生的睡眠之间存在明显差异 指标提出了关于哪种评估方法有效的问题。没有和解差异的方法 在睡眠日记和可穿戴设备之间，临床试验的当前实践是依靠睡眠日记数据 这是次优的，可能会导致试验中的钝性或非显着影响。改善的患者 报告的结果（IPRO） - 睡眠日记是一种方法和系统，旨在通过 结合睡眠日记和可穿戴设备数据，同时保持睡眠评估的主观性。这 建议的解决方案是为患者同时提供可穿戴设备衍生的睡眠数据 睡眠日记的完成。患者报告的睡眠日记测量仍然是感兴趣的结果， 但是，患者可以自由地将其客观数据纳入评估。这 方法的启发是受信号处理理论的启发，其中来自两个传感器的测量 误差源（睡眠日记和可穿戴设备）合并以改善基础的测量 信号。提供患者的客观数据然后使用其睡眠日记反应的方法（在 与平均形式形成对比）用于保留患者的自主权并利用自我报告的数据的好处。 初步数据表明，iPro-Sleep日记非线性可改善睡眠指标的测量精度 并减少设备和睡眠日记数据之间的差异。预计该平台技术将有所改善 在临床试验中对睡眠的评估，并可以更有效地开发有效的治疗。