Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Gary A. Smith, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01169155
First received: July 20, 2010
Last updated: September 9, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Smoke Alarm Stimuli - Adults
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 a linked study with adult participants ages 20-49 to ensure that the alarms tested will also work for adults in this age group. This arm will use the alarm signal identified in Study 2 that are significantly associated with Electroencephalography (EEG)-defined awakening and successful completion of simulated escape behaviors by children after awakening from stage 4 sleep. A lower frequency tone smoke alarm will evaluate the influence of alarm signal frequency on awakening. A conventional residential tone smoke alarm will be used as a reference stimulus. Both a male and a female voice will be used as alarm stimuli. Note that these will be strangers' voices, and not a mother's voice.
Device: smoke alarm stimuli
Each participant receives 4 different smoke alarm stimuli, one per sleep cycle
Active Comparator: Smoke Alarm Stimuli - Older Adults
Phase 2 of this project will consist of Study 3, which will take the voice alarm script in Study 2 and compare it with a low-frequency 520 Hz square wave tone smoke alarm in awakening older adults age 65-84 years old from slow wave sleep and prompting their performance of a simulated escape procedure. Note that this will necessarily be a female stranger's voice, and not a mother's voice, in this older age group. As in Studies 1 and 2, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 3. In order to maintain the same experimental design across these studies, a fourth alarm type will be introduced. This fourth alarm will be a hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm, i.e., the stimulus will begin with the 520 Hz square wave tone in a T-3 pattern followed by the voice script, with this stimulus being repeated until the subject completes the escape procedure.
Device: smoke alarm stimuli
Each participant 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
Criteria

Inclusion Criteria:

  • Child is at least 5 years of age and has not yet had his/her thirteenth birthday.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169155

Contacts
Contact: Gary A. Smith, MD, DrPH 614-722-2400 gary.smith@nationwidechildrens.org

Locations
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         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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, MD, DrPH, 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: September 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Smoke inhalation injury
Burns
Injuries

Additional relevant MeSH terms:
Respiratory Aspiration
Smoke Inhalation Injury
Burns
Burns, Inhalation
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014