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CompletedNCT03053011BRASSARDUpdated Jun 17, 2019

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

An interventional study of Vibrating bracelet in Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance and Healthy Volunteers, sponsored by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Congenital Central Hypoventilation Syndrome
  • Patients With Nocturnal Ventilatory Assistance
  • Healthy Volunteers

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03

In context

Hypoventilation

161 studies on the registry are indexed under Hypoventilation; 28 are open to participants now.

This study's enrollment of 37 is close to the median of 40 across 99 interventional studies indexed under Hypoventilation.

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Lead sponsor

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Vibrating bracelet

    A bracelet with vibrations triggered randomly overnight

    Other: Vibrating bracelet

Interventions

  • OtherVibrating 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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 night

Secondary outcomes

  1. 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

    Time frame: 1 night

  2. Awakening without capability to do the cognitive task

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

    Time frame: 1 night

07

Study locations

1 site
  • Service des pathologies du sommeil - GH Pitié-Salpêtrière
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03053011
Lead sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
Feb 13, 2017
Primary completion
Jun 26, 2018
Completion
Jun 14, 2019
Last update
Jun 17, 2019

Study contacts

Valérie ATTALI, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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