Sleep Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Supportive Care
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