Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 20, 2010 | ||||
| Last Updated Date | February 3, 2011 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01169155 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep | ||||
| Official Title ICMJE | Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep | ||||
| 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 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Device: smoke alarm stimuli
Each child receives 4 different smoke alarm stimuli, one per sleep cycle |
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| Study Arm (s) | Active Comparator: Smoke alarm stimuli
N/A
Intervention: Device: smoke alarm stimuli |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 352 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01169155 | ||||
| Other Study ID Numbers ICMJE | IRB09-00546, 1R49CE001172 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gary A. Smith, Principal Investigator, Nationwide Children's Hospital | ||||
| Study Sponsor ICMJE | Nationwide Children's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nationwide Children's Hospital | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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