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

This study has been completed.
Sponsor:
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01062295
First received: February 3, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention
Sleep
Device: Siesta-System
Device: Standard headrest

Study Type: Interventional
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.

Further study details as provided by Basque Health Service:

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Siesta-System
Use of Siesta-System
Device: Siesta-System
Active Comparator: Standard headrest
Use of standard headrest
Device: Standard headrest

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062295

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

No publications provided by Basque Health Service

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joaquin Duran-Cantolla, Osakidetza/Basque Health Service
ClinicalTrials.gov Identifier: NCT01062295     History of Changes
Other Study ID Numbers: conductores
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
passenger,
sleep,
rest,

ClinicalTrials.gov processed this record on October 23, 2014