Status:
COMPLETED
Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Smoke Inhalation Injury
Burns
Eligibility:
All Genders
5-84 years
Phase:
NA
Brief Summary
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 voic...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2018
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT01169155
Start Date
August 6 2010
End Date
September 21 2018
Last Update
November 5 2019
Active Locations (1)
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1
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205