Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062295
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Information provided by:
Basque Health Service

Brief Summary:

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

Arm Intervention/treatment
Experimental: Siesta-System
Use of Siesta-System
Device: Siesta-System
Active Comparator: Standard headrest
Use of standard headrest
Device: Standard headrest

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults between 30 and 80 years

Exclusion Criteria:

  • People with back pain or hip area on trips of 5 hours. Acute passenger. Serious chronic illness. Depressions. Medicated people with sleep inducing drugs or stimulants. People with insomnia relevant and apnea-hypopnea syndrome during sleep (SAHS) will be excluded by validated sleep test. People who have drunk in the last 6 hours coffee, other drinks, exciting, or an amount of alcohol over a glass of wine and those who stayed more than 30 minutes las12 hours before the test. People who declare themselves unable to relax in a vehicle while riding as co-pilots. Morbid obesity (BMI> 40 kg/m2) and any musculoskeletal disorder defined as a disease that can trouble the rest and sleep onset in a car. Latex allergy.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01062295

Txagorritxu Hospital
Vitoria-Gasteiz, Alava, Spain, 01009
Sponsors and Collaborators
Basque Health Service
Principal Investigator: Joaquin Durán-Cantolla, MD, PhD Osakidetza/ Basque Health System

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joaquin Duran-Cantolla, Osakidetza/Basque Health Service Identifier: NCT01062295     History of Changes
Other Study ID Numbers: conductores
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: October 2009

Keywords provided by Basque Health Service: