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

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche37 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Congenital Central Hypoventilation Syndrome Patients With Nocturnal Ventilatory Assistance Healthy Volunteers

Interventions

Vibrating braceletOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Service des pathologies du sommeil - GH Pitié-Salpêtrière

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 1 night

Secondary Outcomes

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

Time frame: 1 night

Awakening without capability to do the cognitive task

Proportion of the activations of the bracelet causing an awakening without the cognitive task

Time frame: 1 night

Data from ClinicalTrials.gov

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