Clinical Trial: Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Alarm Relay Bracelet for Simplification and Security Respiratory Assistance at Home: Evaluation of the Nocturnal Awakening Capability in Ventilated Patients and Healthy Volunteers

Brief Summary: As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).

Detailed Summary:
Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Current Primary Outcome: Total awakening capability [ Time Frame: 1 night ]

Proportion of the activations of the bracelet causing an awakening sufficient for the subject to stop the application and do a cognitive task : note the wake-up time


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Awakening capability in each stage of sleep [ Time Frame: 1 night ]
    Proportion of awakenings in different stages of sleep (slow wave sleep, Rapid Eye Movement sleep) relative to the total number of vibrations triggering by the bracelet
  • Awakening without capability to do the cognitive task [ Time Frame: 1 night ]
    Proportion of the activations of the bracelet causing an awakening without the cognitive task


Original Secondary Outcome: Same as current

Information By: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Dates:
Date Received: February 2, 2017
Date Started: February 13, 2017
Date Completion: February 12, 2019
Last Updated: February 20, 2017
Last Verified: February 2017