Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest
NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The device is attached to the headrest and is based in a new concept called "dynamic vertical holding of the head and neck". It could also provide some help in avoiding accidents by allowing a sleeping time for a secondary driver while the main one is driving. Several studies have shown that up to 30% of car crashes are related to sleepiness.
AIM: To estimate the efficacy and safety of a new device in "patent pending" phase to facilitate the sleep and rest in the passenger.
METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of 40 different passengers during a journey after using both systems, that is the new device and the standard headrest.
MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B) Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D) Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in recorded images.
ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as well as the images recorded and polysomnographic variables of objective sleep variables obtained by the device Siesta-SystemTM and the conventional headrest.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Supportive Care
|Official Title:||Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest.|
|Study Start Date:||November 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Use of Siesta-System
Active Comparator: Standard headrest
Use of standard headrest
|Device: Standard headrest|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062295
|Vitoria-Gasteiz, Alava, Spain, 01009|
|Principal Investigator:||Joaquin Durán-Cantolla, MD, PhD||Osakidetza/ Basque Health System|