Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 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: January 30, 2016
Last verified: January 2016
  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. 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.


Condition Intervention
Smoke Inhalation Injury
Burns
Other: Smoke Alarm Stimuli

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
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 ]
    Subject awakened by alarm (Yes/No)

  • Escape (Yes/No) [ Time Frame: Day 1 - Immediately following each alarm ] [ Designated as safety issue: No ]
    Subject 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: 708
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: Study 3. Adults 20-49 Years of Age

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, Study 3, with adult participants 20-49 years of age 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 is significantly associated with Electroencephalography (EEG)-defined awakening and successful completion of simulated escape behaviors by children after awakening from slow wave 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.

Other: Smoke Alarm Stimuli
See arm descriptions for information about the smoke alarm stimuli interventions.
Active Comparator: Study 4. Older Adults 60-84 Years of Age
Study 4 of this project 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 60-84 years of age 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 4. 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.
Other: Smoke Alarm Stimuli
See arm descriptions for information about the smoke alarm stimuli interventions.
Active Comparator: Study 1. Maternal Voice Smoke Alarm Characteristics

Study 1. Identification of Specific Maternal Voice Smoke Alarm Characteristics Associated With Awakening and Escaping.

Using a randomized, non-blinded, repeated measures, clinical intervention design, 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 signal that are significantly associated with EEG-defined awakening (and completion of simulated escape behaviors by children after awakening from S4). A conventional residential tone smoke alarm meeting current NFPA 72 National Fire Alarm Code will be used as a reference stimulus to allow comparison of responses to the voice alarm stimuli with responses to a conventional residential tone alarm stimulus.

Other: Smoke Alarm Stimuli
See arm descriptions for information about the smoke alarm stimuli interventions.
Active Comparator: Study 2. Mother's Versus Stranger's Voice Alarms & Alarm Freq.

Study 2. Comparison of Mother's Versus Stranger's Voice Smoke Alarms and Alarm Frequency.

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. This will determine whether mother's voice is a critical factor for success of the voice smoke alarm. In addition, a Temporal-Three (T-3) pattern smoke alarm with dominant tones in lower frequency ranges similar to the human voice range will be included as a stimulus in Study 2 to evaluate the influence of alarm signal frequency on EEG-defined awakening (as well as completion of simulated escape behaviors by children after awakening from S4). As in Study 1, a conventional residential tone smoke alarm will be used as a reference stimulus in Study 2. This conventional residential tone alarm has a higher frequency signal than the other T-3 tone alarm.

Other: Smoke Alarm Stimuli
See arm descriptions for information about the smoke alarm stimuli interventions.
Active Comparator: Study 5. Male Voice and Hybrid Tone/Voice Alarm for Children
Study 5. Children 5-12 Years of Age (Testing Male Voice and Hybrid Tone/Voice Alarm) 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 Study 5 among children 5-12 years of age using the following 4 alarm stimuli: female stranger's voice, male stranger's voice, hybrid of the low-frequency 520 Hz square wave tone smoke alarm and the voice alarm (from Study 4), and conventional high frequency tone residential alarm. This study arm will allow comparison of a male versus female voice and also evaluate the hybrid low frequency tone/voice alarm among children 5-12 years of age. The same protocol will be used for children in this study arm as was used in Studies 1 and 2.
Other: Smoke Alarm Stimuli
See arm descriptions for information about the smoke alarm stimuli interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 84 Years   (Child, Adult, Senior)
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 (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 Criteria:

  • 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.

  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 614-355-5884 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    614-355-5884    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

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: January 30, 2016
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
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Burns, Inhalation
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on December 02, 2016