Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest
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|ClinicalTrials.gov Identifier: NCT01062295|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Device: Siesta-System Device: Standard headrest||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||February 2010|
Use of Siesta-System
Active Comparator: Standard headrest
Use of standard headrest
|Device: Standard headrest|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062295
|Vitoria-Gasteiz, Alava, Spain, 01009|
|Principal Investigator:||Joaquin Durán-Cantolla, MD, PhD||Osakidetza/ Basque Health System|