Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of sleeping device to keeping children in position while riding motor vehicles: a non-blinded single centre controlled crossover interventional randomised trial
Acronym
Study hypothesis
A new (copyrighted) sleeping device will allow children to maintain head, neck and torso in position while asleep during travel, therefore reducing the chances of out of position (OOP) risky behaviors
Ethics approval
University of Navarra Ethics Committee pending as of 22/02/2011
Study design
Single centre randomised controlled unblinded crossover intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sleeping position
Intervention
Comparator:
Regular sleeping aids (if any): pillows, blankets, folded clothing, stuffed animal, etc., anything the child regularly uses when travelling to make him/herself more comfortable.
Intervention:
Siesta System sleeping device, a head suspender device that mimicks the concept of a hammock. The device is copyrighted and patented.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
Percent of the travel time in which the child in out of position as observed by markers placed and recorded with a triaxial camera system that records all the travel.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2010
Overall trial end date
01/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children ages 7-12 (inclusive)
2. Either sex
3. Maximum height 150 cm
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Acute disease at time of experiment
2. Children with travel sickness
3. Morbidly obese children
4. Children with behavioural issues that would make it difficult collaborating in the experiment
5. Does not match inclusion criteria
Recruitment start date
01/09/2010
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Spain
Trial participating centre
European Center for Injury Prevention
Pamplona
31190
Spain
Funders
Funder type
Industry
Funder name
Developer of Siesta System
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary