Overnight Upper Airway Infiltration in Spinal Cord Injury

Online since 10 November 2022, updated 589 days ago

About this trial

Obstructive Sleep Apnea (OSA), a common disorder resulting from repetitive pharyngeal collapse during sleep, is multifactorial. Usually, OSA is considered primarily a problem of upper airway anatomy, ...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C6 - L5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    All
    Healthy volunteers
    No
    C6-L5

    What’s involved

    Type

    Observational

    Details

    All SCI patients meeting inclusion criteria with scheduled polysomnography within the framework of usual care and referred to the sleep laboratory will be proposed to participate. These patients are usually recorded in a dedicated room within PMR units during a 3-day to one-week hospital stay. Information will be given to eligible patients to allow time for reflexion before written consent is collected during the inclusion visit (during the PMR hospitalization or at the sleep laboratory to carry out the night recording). Collection of clinical and demographic data will be performed by a PMR practitioner or sleep physician according to a predefined and standardized evaluation grid. After consent form signature patients willing to participate will undergo "before-sleep" measurement of: Leg fluid volume Neck circumference Neck volume Short questionnaire developed for the needs of the study. Then patients will undergo a full night polysomnography according to the American Academy of sleep Medicine (AASM) guidelines. The sleep recording will be carried out in a dedicated room within the spinal cord injury unit with the immediate proximity of a care team with specific competence in the field of the management of the heaviest patients (e.g: urinary catheterization, stool evacuation, pressure sore prevention, safe transfers, etc.). The reading of the polysomnography will be ensured by a doctor specialized in sleep pathologies without any knowledge of the different impedance measurements, circumference and cervical volume measurements. "After-sleep" measurement will be performed immediately after patients awakening (before any wheelchair transfer): Leg fluid volume Neck circumference Neck volume Short questionnaire developed for the needs of the study. In summary: Before going to bed and before getting up for the first time, each patient will benefit from a standardized evaluation by measuring bioelectrical impedance on the lower limbs, 3D cervical acquisition and measurement of the neck circumference. All of these measurements are non-invasive.

    Potential benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jun 2022
    • Organisation
    • Assistance Publique - Hôpitaux de Paris
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jun 2022
    • Organisation
    • Assistance Publique - Hôpitaux de Paris

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more