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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03053011

Acronym

BRASSARD

Enrollment

Registered

2017-02-14

Start date

2017-02-13

Completion date

2019-06-14

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Central Hypoventilation Syndrome, Healthy Volunteers, Patients With Nocturnal Ventilatory Assistance

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).

Interventions

OTHERVibrating 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Total awakening capability	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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026