Condition category
Not Applicable
Date applied
07/02/2011
Date assigned
07/04/2011
Last edited
08/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Segui-Gomez

ORCID ID

Contact details

European Center for Injury Prevention
School of Medicine
University of Navarra
Ed. Castaños S200
Irunlarrea 1
Pamplona
31190
Spain

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

Sponsor information

Organisation

University of Navarra (Spain)

Sponsor details

c/o Javier Ferro
European Center for Injury Prevention
School of Medicine
University of Navarra
Irunlarrea 1
Pamplona
31190
Spain

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes