Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials to Improve Sleep Quality
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant Satisfaction With Personalized Trial Components
研究概览
简要总结
The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg of melatonin, and the final bottle containing a placebo pill. The first two weeks will be a baseline period, where no supplement is assigned, but data are collected, including self-report of sleep quality and duration and accelerometer-derived sleep and activity data. After successful completion of the baseline period, participants will be randomized to six 2-week intervention blocks of a 3 mg dose melatonin, a 0.5 mg dose melatonin, and a placebo. At the end of the trial, participants will be asked to complete the System Usability Scale, a satisfaction survey (electronic or phone/video call if they are non-responders), and participate in a virtual interview (such as over Microsoft Teams or a phone call) to inform feasibility and acceptability of protocol requirements, study materials, and personalized reports.
详细描述
The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study; to remotely recruit and enroll participants; to assess the feasibility of using a placebo and to determine the feasibility of the proposed methods used to collect and assess participant adherence and response to a wellness strategy (in this case, melatonin for poor sleep quality). This pilot will help determine if an N-of-1 study design, or what has been termed 'Personalized Trials', can have widespread use in future research and clinical practice to address high public health burdens with a high heterogeneity of response. This pilot study will assess feasibility using a Personalized Trials model to evaluate an individual participant's experience with a wellness strategy for self-reported poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg of melatonin, and the final bottle containing placebo pills. Participants will be asked several questions a day sent via text message about their sleep quality, as well as their stress, fatigue, concentration, confidence, mood, and pain levels to demonstrate relevant secondary impacts of sleep quality. Participants will also have access to several videos explaining the protocol. The study will take place over the course of 14 weeks. The first two weeks will be a baseline period, where no supplement is assigned, but data are collected, including self-report of sleep quality and duration and accelerometer-derived sleep and activity data. After successful completion of the baseline period, participants will be randomized to six 2-week intervention blocks of a 3 mg dose melatonin, a 0.5 mg dose melatonin, and a placebo. At the end of the 14 weeks, a report containing the individual's observed data will be prepared for each participant and electronically sent to them along with a satisfaction survey (electronic, or phone/video call if they are non-responders).
After the end of the 14-week trial, participants will receive a summary of their observed data in a personalized report. Creating this type of report will help to assess the feasibility of using a N-of-1 trial design through user-acceptability of sleep quality and wellness-related data visualizations, and the ability to choose preferred intervention (if any) based on the data. Participants will be asked to complete the System Usability Scale, a satisfaction survey (electronic or phone/video call if they are non-responders), and participate in a virtual interview (such as over Microsoft Teams or a phone call) to inform feasibility and acceptability of protocol requirements, study materials, and personalized reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Fluent in English
- •Ability to take melatonin and a placebo
- •Self-report of disrupted sleep symptoms using the Insomnia Symptom Questionnaire (ISQ)
- •Owns and can regularly access a smartphone capable of receiving text messages
- •Owns and can regularly access an e-mail account
- •Lives in the United States
- •Agreement to adhere to lifestyle considerations including wearing a Fitbit device day and night and potentially adapting their current melatonin routine to fit the protocol throughout study duration
排除标准
- •Age < 18 years old
- •Women who are pregnant or breastfeeding
- •Individuals diagnosed with depression, seasonal affective disorder, schizophrenia, autoimmune disease, or asthma
- •Individuals taking MAO inhibitors or corticosteroids
- •Individuals diagnosed with low blood pressure
- •Clinical diagnosis of a sleep disorder (e.g., Narcolepsy, Circadian Rhythm Sleep-Wake Disorders, Periodic Limb Movement Disorder, Restless Leg Syndrome, Obstructive Sleep Apnea etc.)
- •Deemed unable to complete the study protocol as a result of cognitive impairment, severe medical or mental illness, or active or prior substance abuse
- •Participation in shift work (evening/night shifts, early morning shifts, rotating shifts, etc.)
- •Pilot or flight attendant with frequent travel across time zones
- •Receiving specialty mental health care for insomnia (e.g., cognitive behavioral therapy for insomnia, medications for insomnia)
- •Has even been told by a doctor or healthcare provider that it is not safe to take melatonin
- •Does not own or cannot regularly access a smartphone capable of receiving text messages
- •Does not possess or cannot regularly access an email account
- •Lives outside the United States
- •Planned surgeries within 6 months from study start date
结局指标
主要结局
Participant Satisfaction With Personalized Trial Components
时间窗: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
Participants will rate their satisfaction with the Personalized N-of-1 Trial overall and with individual elements of the trial in a satisfaction survey administered following the baseline and intervention periods (14 weeks). Means and standard deviations will be reported for each element of satisfaction. Participants will rate their satisfaction on a scale of 1 to 5, with higher scores indicating greater levels of satisfaction.
Mean System Usability Score (SUS)
时间窗: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.
次要结局
- Mean Participant Adherence to Nightly Placebo Supplement.(Assessed across the two 14-day treatment periods (28 days total).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.(EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).)
- Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement.(Assessed across the two 14-day treatment periods (28 days total).)
- Mean Participant Adherence to Nightly Melatonin 3 mg Supplement.(Assessed across the two 14-day treatment periods (28 days total).)
- Mean Within-Subject Difference in Self-Reported Sleep Quality.(Daily sleep quality will be assessed daily via survey during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each).)
- Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.(EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).)
- Within-Participant Difference in Fitbit Device-Recorded Sleep Duration.(Nightly sleep duration will be assessed consistently via Fitbit device during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).)
- Mean Fitbit Device Adherence Rate.(Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).)