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NCT03053011 Clinical Trial

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

Healthy Volunteers Clinical Trial

— BRASSARD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03053011
Other study ID # 2016-A01044-47
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2017
Est. completion date June 14, 2019

Study information
Verified date June 2019
Source Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date June 14, 2019
Est. primary completion date June 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Vibrating bracelet
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).

Locations
Country Name City State
France Service des pathologies du sommeil - GH Pitié-Salpêtrière Paris

Sponsors (1)
Lead Sponsor Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 night
Secondary 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 1 night
Secondary Awakening without capability to do the cognitive task Proportion of the activations of the bracelet causing an awakening without the cognitive task 1 night
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