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

A

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)

37 participants in 1 patient group

Vibrating bracelet
Experimental group
Description:
A bracelet with vibrations triggered randomly overnight
Treatment:
Other: Vibrating bracelet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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