Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep

Completed · Not applicable

Conditions studied: Smoke Inhalation Injury, Burns

In brief

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.

Key facts

Study ID: NCT01169155
Run by: Nationwide Children's Hospital
People needed: 834
Starts: 2010-08-06
Expected to finish: 2018-09-21
Last updated by the study team: 2019-11-05

Who can join

Age: 5 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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