Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep
Recruitment status was Recruiting
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Purpose
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.
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.
| Condition | Intervention |
|---|---|
|
Smoke Inhalation Injury Burns |
Device: smoke alarm stimuli |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep |
- Awaken (Yes/No) [ Time Frame: Day 1 - Immediately following each alarm ] [ Designated as safety issue: No ]Child awakened by alarm (Yes/No)
- Escape (Yes/No) [ Time Frame: Day 1 - Immediately following each alarm ] [ Designated as safety issue: No ]Child successfully performed simulated escape procedure (Yes/No)
- Time to awaken [ Time Frame: Day 1 - Immediately following each alarm ] [ Designated as safety issue: No ]Time from onset of alarm until EEG-defined awakening
- Time to Escape [ Time Frame: Day 1 - Immediately following each alarm ] [ Designated as safety issue: No ]Time from onset of alarm until child exits sleep room
- Reaction time [ Time Frame: Day 1 - Immediately after awakening ] [ Designated as safety issue: No ]Sleep inertia will be quantitatively measured using a Psychomotor Vigilance Task Monitor device (PVT-192 by Ambulatory Monitoring, Inc.) after subjects awaken.
| Estimated Enrollment: | 352 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Smoke alarm stimuli
N/A
|
Device: smoke alarm stimuli
Each child receives 4 different smoke alarm stimuli, one per sleep cycle
|
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 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.
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.
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 two linked studies. 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 alarm that are significantly associated with Electroencephalography (EEG)-defined awakening and successful completion of simulated escape behaviors by children after awakening from stage 4 sleep. 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. In addition, a lower frequency tone smoke alarm will be included as a stimulus in Study 2 to evaluate the influence of alarm signal frequency on awakening. A conventional residential tone smoke alarm will be used as a reference stimulus in both studies. This proposed research is significant, because it will allow the development of an effective and practical smoke alarm for children, which would provide an opportunity to reduce fire-related morbidity and mortality to children worldwide.
Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Child is at least 5 years of age and has not yet had his/her thirteenth birthday.
- Child is a son or daughter of a Nationwide Children's Hospital employee or receives primary care in a Nationwide Children's Hospital primary care clinic.
- Child and child's caretaker 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").
- 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).
Exclusion Criteria:
- Child has a clinical diagnosis that may affect sleep, arousal or ability to perform the escape procedure.
- Child has a hearing impairment.
- Child is taking medication that may affect sleep, arousal, or ability to perform the escape procedure.
- Child has an acute illness at the time of the sleep study.
Contacts and Locations| Contact: Gary A. Smith, MD, DrPH | 614-722-2400 | gary.smith@nationwidechildrens.org |
| United States, Ohio | |
| The Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Gary A. Smith, MD, DrPH 614-722-2400 gary.smith@nationwidechildrens.org | |
| Principal Investigator: Gary A. Smith, MD, DrPH | |
| Principal Investigator: | Gary A. Smith, MD, DrPH | The Research Institute at Nationwide Children's Hospital |
More Information
No publications provided
| Responsible Party: | Gary A. Smith, Principal Investigator, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01169155 History of Changes |
| Other Study ID Numbers: | IRB09-00546, 1R49CE001172 |
| Study First Received: | July 20, 2010 |
| Last Updated: | February 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nationwide Children's Hospital:
|
Smoke inhalation injury Burns Injuries |
Additional relevant MeSH terms:
|
Burns, Inhalation Respiratory Aspiration Smoking Smoke Inhalation Injury Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Habits Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013