Critical Smoke Alarm Characteristics to Awaken Children From Stage 4 Sleep

NCT01169155 | Completed

• 2 other identifiers: IRB09-005461R49CE001172
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Smoke Inhalation Injury; Burns

Keywords

Smoke inhalation injury; Burns; Injuries

Outcome Measures

Primary Outcomes (4)

• Awaken (Yes/No)

  Subject awakened by alarm (Yes/No)

  Day 1 - Immediately following each alarm

• Escape (Yes/No)

  Subject successfully performed simulated escape procedure (Yes/No)

  Day 1 - Immediately following each alarm

• Time to awaken

  Time from onset of alarm until EEG-defined awakening

  Day 1 - Immediately following each alarm

• Time to Escape

  Time from onset of alarm until child exits sleep room

  Day 1 - Immediately following each alarm

Secondary Outcomes (1)

• Reaction time

  Day 1 - Immediately after awakening

Study Arms (5)

Study 3. Adults 20-49 Years of Age

ACTIVE COMPARATOR

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

Study 4. Older Adults 60-84 Years of Age

ACTIVE COMPARATOR

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

Study 1. Maternal Voice Smoke Alarm Characteristics

ACTIVE COMPARATOR

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

Study 2. Mother's Versus Stranger's Voice Alarms & Alarm Freq.

ACTIVE COMPARATOR

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

Study 5. Male Voice and Hybrid Tone/Voice Alarm for Children

ACTIVE COMPARATOR

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

Interventions

Smoke Alarm Stimuli OTHER

See arm descriptions for information about the smoke alarm stimuli interventions.

Study 1. Maternal Voice Smoke Alarm Characteristics; Study 2. Mother's Versus Stranger's Voice Alarms & Alarm Freq.; Study 3. Adults 20-49 Years of Age; Study 4. Older Adults 60-84 Years of Age; Study 5. Male Voice and Hybrid Tone/Voice Alarm for Children

Eligibility Criteria

• Age: 5 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Smith GA, Chounthirath T, Splaingard M. Effectiveness of a Voice Smoke Alarm Using the Child's Name for Sleeping Children: A Randomized Trial. J Pediatr. 2019 Feb;205:250-256.e1. doi: 10.1016/j.jpeds.2018.09.027. Epub 2018 Oct 25.

  PMID: 30482491 DERIVED

MeSH Terms

Conditions

Smoke Inhalation Injury; Burns; Wounds and Injuries

Condition Hierarchy (Ancestors)

Burns, Inhalation

Study Officials

• Gary A. Smith, MD, DrPH

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DrPH

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 26, 2010
• Study Start: August 6, 2010
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

US (1)