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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062295
• Other study ID #: conductores
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: February 3, 2010
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2009
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• Siesta-System

• Standard headrest

Locations

Country	Name	City	State
Spain	Txagorritxu Hospital	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain,