Congenital Central Hypoventilation SyndromeBRASSARDNCT03053011
Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD)
A study testing Vibrating bracelet in people with Congenital Central Hypoventilation Syndrome and Patients With Nocturnal Ventilatory Assistance, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance, Healthy Volunteers
- What is being tested?
- Vibrating bracelet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2017to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service des pathologies du sommeil - GH Pitié-Salpêtrière
Paris, 75013
About this study
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
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).
- Conditions
- Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance, Healthy Volunteers
- Being tested
- Vibrating bracelet
- Medical subject headings
- Congenital central hypoventilation syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating braceletOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Vibrating bracelet | Experimental | A bracelet with vibrations triggered randomly overnight Receives: Other: Vibrating bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 night
Secondary outcomes (2)
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
Measured: 1 night
Awakening without capability to do the cognitive task
Proportion of the activations of the bracelet causing an awakening without the cognitive task
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start13 Feb 2017
- Primary completion26 Jun 2018
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Central Hypoventilation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie ATTALI, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053011
- Sponsor's protocol ID
- 2016-A01044-47
- Acronym
- BRASSARD
- Status last verified
- Jun 2019
- First submitted
- 2 Feb 2017
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03053011
- Acronym / sponsor ID
- BRASSARD / 2016-A01044-47
- Conditions
- Congenital Central Hypoventilation Syndrome, Patients With Nocturnal Ventilatory Assistance, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrating bracelet | Experimental | Other: Vibrating braceletA bracelet with vibrations triggered randomly overnight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating braceletA bracelet with vibrations triggered randomly overnight. The sleeper's awakening capability will be evaluated each time the bracelet vibrates (5 times in the night). | Other | Vibrating bracelet |
Primary outcome
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
2 secondary outcomes
Awakening capability in each stage of sleep
Time frame: 1 night
Awakening without capability to do the cognitive task
Time frame: 1 night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Related trials for Congenital Central Hypoventilation Syndrome
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)
Congenital Central Hypoventilation Syndrome, Congenital Central Hypoventilation
RecruitingObservational study
International Congenital Central Hypoventilation Syndrome (CCHS) Registry and CCHS SHARE
Congenital Central Hypoventilation Syndrome
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruiting
Identifying Biomarkers & Dysregulated Biological Pathways in Blood and Urine of Congenital Central Hypoventilation Syndrome (CCHS) Patients
Congenital Central Hypoventilation Syndrome (CCHS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie ATTALI, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating bracelet in people with Congenital Central Hypoventilation Syndrome and Patients With Nocturnal Ventilatory Assistance, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total awakening capability (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.