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Completed

NCT Number: NCT03053011

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

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).

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Key information

Conditions

Congenital Central Hypoventilation Syndrome Healthy Volunteers Patients With Nocturnal Ventilatory Assistance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service des pathologies du sommeil - GH Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrating bracelet

Other

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).

Primary outcomes

  1. Total awakening capability

    Time frame: 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 outcomes

  1. Awakening capability in each stage of sleep

    Time frame: 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

  2. Awakening without capability to do the cognitive task

    Time frame: 1 night

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: BRASSARD

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 14, 2017
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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