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

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

Status: Completed

Conditions: Congenital Central Hypoventilation Syndrome; Patients With Nocturnal Ventilatory Assistance; Healthy Volunteers

Treatments: Other: Vibrating bracelet

Study type: Interventional

Funder types: Other

Identifiers

NCT03053011

2016-A01044-47

Details and patient eligibility

About

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).

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Vibrating bracelet

Experimental group

Description:

A bracelet with vibrations triggered randomly overnight

Treatment:

Other: Vibrating bracelet