PDF(Pubmed)
Abstract：
BACKGROUND: Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions.
OBJECTIVE: This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep.
METHODS: Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants\' ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants\' self-reported sleep quality and duration and Fitbit tracker-measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection.
RESULTS: As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023.
CONCLUSIONS: Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research-is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board.
BACKGROUND: ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188.
UNASSIGNED: DERR1-10.2196/45313.
OBJECTIVE: This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep.
METHODS: Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants\' ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants\' self-reported sleep quality and duration and Fitbit tracker-measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection.
RESULTS: As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023.
CONCLUSIONS: Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research-is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board.
BACKGROUND: ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188.
UNASSIGNED: DERR1-10.2196/45313.
摘要：
背景：睡眠不好，定义为持续时间短或质量差的睡眠，是一种经常报告的疾病，具有许多有害影响，包括认知功能较差，事故增加,和较差的健康。褪黑激素已被证明是一种有效的治疗方法，可以控制睡眠不良的症状。然而,褪黑素对睡眠的治疗效果在参与者之间差异很大。个性化,或N-of-1，试验设计代表了一种为个体参与者确定最佳治疗方法的方法。尽管使用褪黑激素的N-of-1试验来治疗睡眠不良是可能的，可行性,可接受性,使用褪黑激素的N-of-1试验的有效性尚不清楚。使用美国国立卫生研究院的行为干预发展阶段模型，阶段IB(干预细化，修改,以及适应和试点测试)设计似乎需要解决这些可行性问题。
目的：本试验系列评估可行性，可接受性,在60名参与者中，远程提供褪黑激素剂量（3和0.5mg）与安慰剂补充剂的一系列个性化干预措施对自我报告的睡眠不良的有效性。这项研究的目的是提供有关实施远程N-of-1随机对照试验以改善睡眠不良的有价值的信息。
方法：参与者将完成2周的基线，然后进行6个3mg褪黑激素的2周交替干预期，0.5毫克褪黑激素，和安慰剂。参与者将被随机分配到2个干预命令。个性化试验方法的可行性和可接受性将取决于参与者对遥控器的可用性和满意度的评级，个性化干预递送系统。干预的有效性将使用参与者自我报告的睡眠质量和持续时间以及Fitbit跟踪器测量的睡眠持续时间和效率来测量。其他措施将包括疲劳的生态瞬时评估措施，压力，疼痛,心情,浓度,和信心以及参与者坚持干预的措施，使用Fitbit跟踪器，和调查数据收集。
结果：在提交本方案时，美国国立卫生研究院IB期个性化试验系列的招募完成约78.3%(47/60).我们预计招聘和数据收集将于2023年6月完成。
结论：评估可行性，可接受性,一系列褪黑激素个性化干预措施的有效性将解决该研究计划的长期目标-整合N-of-1试验是否有用患者护理？个性化试验系列结果将发表在同行评审的期刊上，并将遵循CONSORT（报告试验合并标准）扩展为N-of-1试验（CENT2015）报告指南。该试验系列得到了NorthwellHealth机构审查委员会的批准。
背景：ClinicalTrials.govNCT05349188;https://www.clinicaltrials.gov/研究/NCT05349188。
■DERR1-10.2196/45313。
目的：本试验系列评估可行性，可接受性,在60名参与者中，远程提供褪黑激素剂量（3和0.5mg）与安慰剂补充剂的一系列个性化干预措施对自我报告的睡眠不良的有效性。这项研究的目的是提供有关实施远程N-of-1随机对照试验以改善睡眠不良的有价值的信息。
方法：参与者将完成2周的基线，然后进行6个3mg褪黑激素的2周交替干预期，0.5毫克褪黑激素，和安慰剂。参与者将被随机分配到2个干预命令。个性化试验方法的可行性和可接受性将取决于参与者对遥控器的可用性和满意度的评级，个性化干预递送系统。干预的有效性将使用参与者自我报告的睡眠质量和持续时间以及Fitbit跟踪器测量的睡眠持续时间和效率来测量。其他措施将包括疲劳的生态瞬时评估措施，压力，疼痛,心情,浓度,和信心以及参与者坚持干预的措施，使用Fitbit跟踪器，和调查数据收集。
结果：在提交本方案时，美国国立卫生研究院IB期个性化试验系列的招募完成约78.3%(47/60).我们预计招聘和数据收集将于2023年6月完成。
结论：评估可行性，可接受性,一系列褪黑激素个性化干预措施的有效性将解决该研究计划的长期目标-整合N-of-1试验是否有用患者护理？个性化试验系列结果将发表在同行评审的期刊上，并将遵循CONSORT（报告试验合并标准）扩展为N-of-1试验（CENT2015）报告指南。该试验系列得到了NorthwellHealth机构审查委员会的批准。
背景：ClinicalTrials.govNCT05349188;https://www.clinicaltrials.gov/研究/NCT05349188。
■DERR1-10.2196/45313。
