Back to resultsEvaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD) (BRASSARD)
Primary Purpose
Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance, Healthy Volunteers
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vibrating bracelet
Sponsored by
About this trial
This is an interventional basic science trial for Congenital Central Hypoventilation Syndrome
Eligibility Criteria
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
Sites / Locations
- Service des pathologies du sommeil - GH Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vibrating bracelet
Arm Description
A bracelet with vibrations triggered randomly overnight
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Awakening without capability to do the cognitive task
Proportion of the activations of the bracelet causing an awakening without the cognitive task
Full Information
NCT ID
NCT03053011
First Posted
February 2, 2017
Last Updated
June 14, 2019
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT03053011
Brief Title
Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance, Healthy Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibrating bracelet
Arm Type
Experimental
Arm Description
A bracelet with vibrations triggered randomly overnight
Intervention Type
Other
Intervention Name(s)
Vibrating bracelet
Intervention Description
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 Outcome Measure Information:
Title
Total awakening capability
Description
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
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Awakening capability in each stage of sleep
Description
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
Time Frame
1 night
Title
Awakening without capability to do the cognitive task
Description
Proportion of the activations of the bracelet causing an awakening without the cognitive task
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie ATTALI, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des pathologies du sommeil - GH Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)
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