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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Congenital Central Hypoventilation Syndrome; Patients With Nocturnal Ventilatory Assistance
• Intervention / Treatment: Other: Vibrating bracelet

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service des pathologies du sommeil - GH Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• speak french
• with social security For healthy volunteers : no sleep disorder, known neurological or respiratory pathology For patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months.

Exclusion Criteria:

• subjects taking treatment that may interfere with sleep patterns
• intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibrating bracelet; A bracelet with vibrations triggered randomly overnight	Other: Vibrating bracelet; A bracelet with vibrations triggered randomly overnight. The sleeper's awakening capability will be evaluated each time the bracelet vibrates (5 times in the night).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total awakening capability	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	1 night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awakening capability in each stage of sleep	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	1 night
Awakening without capability to do the cognitive task	Proportion of the activations of the bracelet causing an awakening without the cognitive task	1 night

Collaborators and Investigators

• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Investigators: Principal Investigator: Valérie ATTALI, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): June 26, 2018
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: 2016-A01044-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No