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Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep

2019年11月1日 更新者:Gary A. Smith、Nationwide Children's Hospital

Specific Aim 1 is to test the hypothesis that there are specific characteristics of a voice smoke alarm (i.e., use of child's first name, behavior commands in the message content, use of mother's voice, and stimulus frequency) that will awaken children 5-12 years old in stage 4 sleep. The successful children's alarm will be tested among adult subjects to evaluate effectiveness across the age spectrum.

Specific Aim 2 is to test the hypothesis that there are specific characteristics of a voice smoke alarm (i.e., use of mother's voice and behavior commands in the message content) that will result in successful completion of simulated escape behaviors by children 5-12 years old after awakening from stage 4 sleep. The successful children's alarm will be tested among adult subjects to evaluate effectiveness across the age spectrum.

研究概览

地位

完全的

详细说明

Being asleep at the time of a residential fire is an important risk factor for fire-related death. Children 5-12 years of age are unlikely to be awakened by a conventional residential tone smoke alarm in the event of a fire. However, findings from our preliminary research strongly suggest that an effective and practical alarm for this age group is achievable. Building on our previous work, the objective of this study is to determine key smoke alarm characteristics that will awaken children and prompt their escape. We will achieve our study objective through two specific aims.

Specific Aim 1 is to test the hypothesis that there are specific characteristics of a voice smoke alarm (i.e., use of child's first name, behavior commands in the message content, use of mother's voice, and stimulus frequency) that will awaken children 5-12 years old in stage 4 sleep. The successful children's alarm will be tested among adult subjects to evaluate effectiveness across the age spectrum.

Specific Aim 2 is to test the hypothesis that there are specific characteristics of a voice smoke alarm (i.e., use of mother's voice and behavior commands in the message content) that will result in successful completion of simulated escape behaviors by children 5-12 years old after awakening from stage 4 sleep. The successful children's alarm will be tested among adult subjects to evaluate effectiveness across the age spectrum.

Using a randomized, non-blinded, repeated measures, clinical intervention design, our two working hypotheses as stated in Specific Aims 1 and 2 will be tested in five linked studies.

Study 1. Identification of Specific Maternal Voice Smoke Alarm Characteristics Associated With Awakening and Escaping.

Using a randomized, non-blinded, repeated measures, clinical intervention design, Study 1 will identify the critical elements (i.e., use of child's first name and/or behavior commands in message content) in the maternal voice signal that are significantly associated with EEG-defined awakening (and completion of simulated escape behaviors by children after awakening from S4). A conventional residential tone smoke alarm meeting current NFPA 72 National Fire Alarm Code will be used as a reference stimulus to allow comparison of responses to the voice alarm stimuli with responses to a conventional residential tone alarm stimulus.

Alarm stimuli are being tested during S4 in our study, because this is the deepest stage of sleep and the most refractory to arousal. If alarm stimuli are successful in awakening children from S4 and prompting them to escape, then these stimuli will be expected to be at least this successful during other stages of sleep. We want to develop an alarm that provides an effective stimulus for sleeping children at highest risk of non-response.

During Study 1, subjects will be randomly assigned to a sequence of four alarm stimuli using a Latin Square design, which will minimize the possibility of a sequence effect. Block randomization by age range (5-6, 7-8, 9-10, 11-12 years) and gender will be used to ensure that these two variables are equally represented in each of the sequences. A different alarm stimulus will be given during each S4 period of the first and second sleep cycles on two separate non-consecutive nights. Consecutive nights of testing will not be done to avoid possible confounding effects of sleep deprivation. This study's repeated measures design avoids potential confounding effects due to variation of AATs among individuals (inter-subject variability) and takes advantage of the stability of AATs for an individual among sleep cycles during a night and from night to night (intra-subject variability) (Bonnet, et al., 1978; Zepelin, et al., 1984; Bruck, 2001).

Study 2. Comparison of Mother's Versus Stranger's Voice Smoke Alarms and Alarm Frequency.

Study 2 will take the voice alarm script that was the most successful in Study 1 in awakening and prompting children to perform the simulated escape behaviors, and will compare mother's voice to a female stranger's voice using this script. This will determine whether mother's voice is a critical factor for success of the voice smoke alarm. In addition, a Temporal-Three (T-3) pattern smoke alarm with dominant tones in lower frequency ranges similar to the human voice range will be included as a stimulus in Study 2 to evaluate the influence of alarm signal frequency on EEG-defined awakening (as well as completion of simulated escape behaviors by children after awakening from S4). As in Study 1, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 2. This conventional residential tone alarm has a higher frequency signal than the other T-3 tone alarm.

If more than one alarm script ties for the most effective in Study 1, then the script that is the least personalized will be used in Study 2. This decision rule is based on injury prevention theory (Baker, 1981) that dictates that a voice alarm that requires the least effort by the parent (to personalize the script with the child's name in this case) will be more likely to be implemented. Indeed, the voice alarm that would be most likely to be used by parents, and the most likely to be used correctly, is one that requires no personalization at all. For example, if a voice alarm with a pre-recorded, effective, fire safety-appropriate, urgent evacuation message (equivalent to "Wake up! Get out of bed! Leave the room!" by the female stranger's voice in this proposed study) could be purchased, and installed by parents directly from its package, it would be the most likely to result in the needed protection. If our study demonstrates that personalization of an alarm message (by use of the child's first name and mother's voice) is not associated with improved awakening and escaping, then this could eliminate the need for a recording mechanism in a voice smoke alarm, such as currently found in the KidSmart alarm. Decreasing the technical complexity of the alarm will bring down the price, which could increase its use in lower income homes at higher risk of residential fire.

The lower frequency T-3 alarm that will be used in this Study 2 is a Simplex 1996, 4100 Fire Alarm with a fundamental frequency at 500Hz with additional dominant frequencies at 1500Hz and 2500Hz. This is the same alarm previously used by Proulx and Laroche (2003) and Bruck, et al. (2004). Although use of this alarm does not evaluate the influence of alteration of the frequency of the voice alarm stimulus on awakening, it does allow for testing the effects of alarm frequency on awakening by comparing the success of the lower frequency T-3 alarm with the other alarms in Study 2. Since July 1996, the NFPA 72 National Fire Alarm Code has required that buildings equipped with a fire alarm system must sound the Temporal-Three (T-3) pattern as defined by ISO 8201 (International Organization for Standardization, 1987). The international standard addresses the signal's length, sound pressure level, and temporal aspects, but does not stipulate requirements for signal frequency. However, Bruck, et al. (2004) have suggested that alarm frequency may be the key factor in awakening sleeping children.

Using the same design as in Study 1, subjects in Study 2 will be block randomized by age range and gender to a sequence of four alarm stimuli using a Latin Square design. Using a repeated measures design, a different alarm stimulus will be given during each S4 period of the first and second sleep cycles on two separate non-consecutive nights.

Study 3. Active Comparator: Adults 20-49 Years of Age Using a randomized, non-blinded, repeated measures, clinical intervention design, our two working hypotheses as stated in Specific Aims 1 and 2 will be tested in a linked study, Study 3, with adult participants 20-49 years of age to ensure that the alarms tested will also work for adults in this age group. This arm will use the alarm signal identified in Study 2 that is significantly associated with Electroencephalography (EEG)-defined awakening and successful completion of simulated escape behaviors by children after awakening from slow wave sleep. A lower frequency tone smoke alarm will evaluate the influence of alarm signal frequency on awakening. A conventional residential tone smoke alarm will be used as a reference stimulus. Both a male and a female voice will be used as alarm stimuli. Note that these will be strangers' voices, and not a mother's voice.

Study 4. Active Comparator: Older Adults 60-84 Years of Age Study 4 of this project will take the voice alarm script in Study 2 and compare it with a low-frequency 520 Hz square wave tone smoke alarm in awakening older adults 60-84 years of age from slow wave sleep and prompting their performance of a simulated escape procedure. Note that this will necessarily be a female stranger's voice, and not a mother's voice, in this older age group. As in Studies 1 and 2, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 4. In order to maintain the same experimental design across these studies, a fourth alarm type will be introduced. This fourth alarm will be a hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm, i.e., the stimulus will begin with the 520 Hz square wave tone in a T-3 pattern followed by the voice script, with this stimulus being repeated until the subject completes the escape procedure. The simulated escape procedure for older adults will be different from that of the child and adult (20-49 years of age) studies (Studies 1, 2, and 3). It will consist of the participant sitting up in his/her bed and pressing a button anchored to the wall beside the bed to stop the alarm. This will avoid any concerns of falls in this older age group upon awakening.

Study 5. Children 5-12 Years of Age (Testing Male Voice and Hybrid Tone/Voice Alarm) Using a randomized, non-blinded, repeated measures, clinical intervention design, our two working hypotheses as stated in Specific Aims 1 and 2 will be tested in Study 5 among children 5-12 years of age using the following 4 alarm stimuli: female stranger's voice, male stranger's voice, hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm (from Study 4), and conventional high frequency tone residential alarm. This study arm will allow comparison of a male versus female voice and also evaluate the hybrid low frequency tone/voice alarm among children 5-12 years of age. The same protocol will be used for children in this study arm as was used in Studies 1 and 2.

研究类型

介入性

注册 (实际的)

834

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Columbus、Ohio、美国、43205
        • The Research Institute at Nationwide Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 84年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Child is at least 5 years of age and has not yet had his/her thirteenth birthday (for Studies # 1, 2, and 5).
  • Subject (and child's caretaker for Studies #1, 2, and 5) speak English (2000 Census data indicate that less than 5% of the population older than five years of age in Franklin County, Ohio [where the study is located] speaks English less than "very well").
  • Subject/family is able to be contacted by telephone (to obtain pre-study information and to remind the family about the study appointment and confirm that the child is in a normal state of health on day of study).
  • For adult study arms: Study 3: Subjects are 20-49 years of age; Study 4: Subjects are 60-84 years of age.

Exclusion Criteria:

  • Subject has a clinical diagnosis that may affect sleep, arousal or ability to perform the escape procedure.
  • Subject has a hearing impairment.
  • Subject is taking medication that may affect sleep, arousal, or ability to perform the escape procedure.
  • Subject has an acute illness at the time of the sleep study.

The target population for Study 3 consists of adults 20-49 years of age, who have not yet had his/her fiftieth birthday. Adult participants must not have a clinical diagnosis that may affect sleep, arousal or ability to perform the simulated escape procedure. He/she must not have a hearing impairment; not be taking medication that may affect sleep, arousal, or ability to perform the escape procedure; and not have an acute illness at the time of the sleep study. The adult must speak English and be able to be contacted by telephone (to obtain pre-study information and to remind the participant about the study appointment and confirm that he/she is in a normal state of health on the day of the study).

The target population for Study 4 consists of older adults 60-84 years of age, who have not yet had his/her eighty-fifth birthday. The older adult must not have a clinical diagnosis that may affect sleep, arousal or ability to perform the escape; not have a hearing impairment; and not be taking medication that may affect sleep, arousal, or ability to perform the simulated escape procedure. The older adult must not have an acute illness at the time of the sleep study. The older adult must speak English and be able to be contacted by telephone (to obtain pre-study information and to remind the participant about the study appointment and confirm that he/she is in a normal state of health on the day of the study).

The target population for Study 5 is the same as that for Studies 1 and 2.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Study 3. Adults 20-49 Years of Age

Using a randomized, non-blinded, repeated measures, clinical intervention design, our two working hypotheses as stated in Specific Aims 1 and 2 will be tested in a linked study, Study 3, with adult participants 20-49 years of age to ensure that the alarms tested will also work for adults in this age group.

This arm will use the alarm signal identified in Study 2 that is significantly associated with Electroencephalography (EEG)-defined awakening and successful completion of simulated escape behaviors by children after awakening from slow wave sleep. A lower frequency tone smoke alarm will evaluate the influence of alarm signal frequency on awakening. A conventional residential tone smoke alarm will be used as a reference stimulus. Both a male and a female voice will be used as alarm stimuli. Note that these will be strangers' voices, and not a mother's voice.

See arm descriptions for information about the smoke alarm stimuli interventions.
有源比较器:Study 4. Older Adults 60-84 Years of Age
Study 4 of this project will take the voice alarm script in Study 2 and compare it with a low-frequency 520 Hz square wave tone smoke alarm in awakening older adults 60-84 years of age from slow wave sleep and prompting their performance of a simulated escape procedure. Note that this will necessarily be a female stranger's voice, and not a mother's voice, in this older age group. As in Studies 1 and 2, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 4. In order to maintain the same experimental design across these studies, a fourth alarm type will be introduced. This fourth alarm will be a hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm, i.e., the stimulus will begin with the 520 Hz square wave tone in a T-3 pattern followed by the voice script, with this stimulus being repeated until the subject completes the escape procedure.
See arm descriptions for information about the smoke alarm stimuli interventions.
有源比较器:Study 1. Maternal Voice Smoke Alarm Characteristics

Study 1. Identification of Specific Maternal Voice Smoke Alarm Characteristics Associated With Awakening and Escaping.

Using a randomized, non-blinded, repeated measures, clinical intervention design, Study 1 will identify the critical elements (i.e., use of child's first name and/or behavior commands in message content) in the maternal voice signal that are significantly associated with EEG-defined awakening (and completion of simulated escape behaviors by children after awakening from S4). A conventional residential tone smoke alarm meeting current NFPA 72 National Fire Alarm Code will be used as a reference stimulus to allow comparison of responses to the voice alarm stimuli with responses to a conventional residential tone alarm stimulus.

See arm descriptions for information about the smoke alarm stimuli interventions.
有源比较器:Study 2. Mother's Versus Stranger's Voice Alarms & Alarm Freq.

Study 2. Comparison of Mother's Versus Stranger's Voice Smoke Alarms and Alarm Frequency.

Study 2 will take the voice alarm script that was the most successful in Study 1 in awakening and prompting children to perform the simulated escape behaviors, and will compare mother's voice to a female stranger's voice using this script. This will determine whether mother's voice is a critical factor for success of the voice smoke alarm. In addition, a Temporal-Three (T-3) pattern smoke alarm with dominant tones in lower frequency ranges similar to the human voice range will be included as a stimulus in Study 2 to evaluate the influence of alarm signal frequency on EEG-defined awakening (as well as completion of simulated escape behaviors by children after awakening from S4). As in Study 1, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 2. This conventional residential tone alarm has a higher frequency signal than the other T-3 tone alarm.

See arm descriptions for information about the smoke alarm stimuli interventions.
有源比较器:Study 5. Male Voice and Hybrid Tone/Voice Alarm for Children
Study 5. Children 5-12 Years of Age (Testing Male Voice and Hybrid Tone/Voice Alarm) Using a randomized, non-blinded, repeated measures, clinical intervention design, our two working hypotheses as stated in Specific Aims 1 and 2 will be tested in Study 5 among children 5-12 years of age using the following 4 alarm stimuli: female stranger's voice, male stranger's voice, hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm (from Study 4), and conventional high frequency tone residential alarm. This study arm will allow comparison of a male versus female voice and also evaluate the hybrid low frequency tone/voice alarm among children 5-12 years of age. The same protocol will be used for children in this study arm as was used in Studies 1 and 2.
See arm descriptions for information about the smoke alarm stimuli interventions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Awaken (Yes/No)
大体时间:Day 1 - Immediately following each alarm
Subject awakened by alarm (Yes/No)
Day 1 - Immediately following each alarm
Escape (Yes/No)
大体时间:Day 1 - Immediately following each alarm
Subject successfully performed simulated escape procedure (Yes/No)
Day 1 - Immediately following each alarm
Time to awaken
大体时间:Day 1 - Immediately following each alarm
Time from onset of alarm until EEG-defined awakening
Day 1 - Immediately following each alarm
Time to Escape
大体时间:Day 1 - Immediately following each alarm
Time from onset of alarm until child exits sleep room
Day 1 - Immediately following each alarm

次要结果测量

结果测量
措施说明
大体时间
Reaction time
大体时间:Day 1 - Immediately after awakening
Sleep inertia will be quantitatively measured using a Psychomotor Vigilance Task Monitor device (PVT-192 by Ambulatory Monitoring, Inc.) after subjects awaken.
Day 1 - Immediately after awakening

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gary A. Smith, MD, DrPH、The Research Institute at Nationwide Children's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年8月6日

初级完成 (实际的)

2018年9月21日

研究完成 (实际的)

2018年9月21日

研究注册日期

首次提交

2010年7月20日

首先提交符合 QC 标准的

2010年7月23日

首次发布 (估计)

2010年7月26日

研究记录更新

最后更新发布 (实际的)

2019年11月5日

上次提交的符合 QC 标准的更新

2019年11月1日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB09-00546
  • 1R49CE001172 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Smoke Alarm Stimuli的临床试验

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