NCT03053011

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

February 2, 2017

Last Update Submit

June 14, 2019

Conditions

Congenital Central Hypoventilation SyndromePatients With Nocturnal Ventilatory AssistanceHealthy Volunteers

Outcome Measures

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

    1 night

Secondary Outcomes (2)

  • Awakening capability in each stage of sleep

    1 night

  • Awakening without capability to do the cognitive task

    1 night

Study Arms (1)

Vibrating bracelet

EXPERIMENTAL

A bracelet with vibrations triggered randomly overnight

Other: Vibrating bracelet

Interventions

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).

Vibrating bracelet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des pathologies du sommeil - GH Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Congenital central hypoventilation syndrome

Study Officials

  • Valérie ATTALI, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 14, 2017

Study Start

February 13, 2017

Primary Completion

June 26, 2018

Study Completion

June 14, 2019

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

FR(1)