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

Not Applicable

Completed

• Conditions: Congenital Central Hypoventilation Syndrome; Patients With Nocturnal Ventilatory Assistance; Healthy Volunteers
• Interventions: Other: Vibrating bracelet

• Registration Number: NCT03053011
• Lead Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-10
• Study Start: 2017-02-13
• Study First Posted: 2017-02-14
• Primary Completion: 2018-06-26
• Status Verified: 2019-06
• Study Completion: 2019-06-14
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vibrating bracelet	Vibrating bracelet	A bracelet with vibrations triggered randomly overnight

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service des pathologies du sommeil - GH Pitié-Salpêtrière; 🇫🇷 Paris, France