Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 834
- 试验地点
- 2
- 主要终点
- Awaken (Yes/No)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 84 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Awaken (Yes/No)
时间窗: Day 1 - Immediately following each alarm
Subject awakened by alarm (Yes/No)
Time to awaken
时间窗: Day 1 - Immediately following each alarm
Time from onset of alarm until EEG-defined awakening
Escape (Yes/No)
时间窗: Day 1 - Immediately following each alarm
Subject successfully performed simulated escape procedure (Yes/No)
Time to Escape
时间窗: Day 1 - Immediately following each alarm
Time from onset of alarm until child exits sleep room
次要结局
- Reaction time(Day 1 - Immediately after awakening)
研究者
Gary A. Smith
MD, DrPH
Nationwide Children's Hospital