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Overnight Upper Airway Infiltration in Spinal Cord Injury (OUI-SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05391308
Recruitment Status : Not yet recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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, with the craniofacial structure or neck fat decreasing the size of the pharyngeal airway lumen. Obesity, male sex and genetics are well established pathogenic factors. In the last decade rostral fluid displacement (fluid shift) to explain the pathogenesis of upper airway collapsibility has been increasingly studied.

Individuals living with spinal cord injury are at increased risk for OSA, with a prevalence that is three- to fourfold higher than the general population. Individual with acute tetraplegia and undiagnosed or untreated OSA may participate less in rehabilitation due to sleepiness and fatigue and therefore be less engaged in activities that improve quality of life and maintain functioning over time. Intermittent hypoxia, sleep fragmentation and alterations of the autonomous nervous system induced by OSA are thought to delay or limit recovery and in the long term, increase cardio- and cerebrovascular morbi-mortality.

Redolfi et al have shown that overnight change in leg fluid volume correlated strongly with the Apnea Hypopnea index (AHI) and the time spent sitting. In SCI patients two mechanisms may underline fluid shift importance in the pathogenesis of OSA: first, time spent sitting is obviously increased in patients with no walking abilities (prolonged sitting position in wheelchair). Secondly, motor deficit lead to the loss of skeletal muscle pumping activity which could promote leg fluid accumulation during the day.

In our knowledge, no study has specifically assessed the impact of rostral fluid displacement on upper airway collapsibility among patients with spinal cord injury.

Better comprehension of upper airway collapsibility determinants in patients with spinal cord injury is mandatory to identify new therapeutic targets (diuretics, contention…) especially since CPAP, the first line treatment for severe OSA, continue to pose adherence issues in SCI patients. In the future, phenotyping OSA patients, especially those with SCI, will improve personalized management.

The main objective is to find if there is a correlation between the apnea-hypopnea index (AHI) and rostral fluid shift overnight, in non-obese spinal cord injured patients. The secondary aim is to find if there is a correlation between AHI and:

  • Neck circumference
  • Neck volume
  • Time spent sitting down

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Spinal Cord Injuries Other: Pre-polysomnography mesurement Other: Polysomnography measure Other: Post-polysomnography measurements Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Overnight Rostral Fluid Shift in the Pathogenesis of Obstructive Sleep Apnea in Spinal Cord Injured Patients
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
All patients will have pre-polysomnographie and post-polysomnographie mesurement.
Other: Pre-polysomnography mesurement
Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner), time spent sitting down (self-reporting)

Other: Polysomnography measure
Apnea-Hypopnea Index

Other: Post-polysomnography measurements
Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner)




Primary Outcome Measures :
  1. Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and the overnight change in leg fluid volume (bioelectrical impedance) [ Time Frame: 18 hours ]

    AHI is used to diagnose OSA by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.

    AHI defines severity as well, the index is:

    • Mild, between 5 and 15 per hour
    • Moderate, between 15 and 30 per hour
    • Severe, over than 30 per hour Leg fluid volume is measured by bioelectrical impedance before and after the night of polysomnography. Intra- and extracellular water are measured in L. Patient is lying down during the measure.


Secondary Outcome Measures :
  1. Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck circumference (tape measure) [ Time Frame: 18 hours ]

    AHI is used to diagnose OSA by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.

    AHI defines severity as well, the index is:

    • Mild, between 5 and 15 per hour
    • Moderate, between 15 and 30 per hour
    • Severe, over than 30 per hour Neck circumference is measured by tape measure before and after the night of polysomnography. The circumference is measured at the superior border of the cricothyroid cartilage. The measure is in cm. Patient is lying down during the measure.


Other Outcome Measures:
  1. Tertiary outcome: Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck volume (3D scanner) [ Time Frame: 18 hours ]

    AHI is used to diagnose OSA by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.

    AHI defines severity as well, the index is:

    • Mild, between 5 and 15 per hour
    • Moderate, between 15 and 30 per hour
    • Severe, over than 30 per hour Neck volume is recovered through the analysis of images made with the 3D scanner, before and after the night of polysomnography. Volume is in mm3. Patient is lying down during the measure.

  2. Quaternary outcome: Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and time spent sitting down [ Time Frame: 18 hours ]

    AHI is used to diagnose OSA by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.

    AHI defines severity as well, the index is:

    • Mild, between 5 and 15 per hour
    • Moderate, between 15 and 30 per hour
    • Severe, over than 30 per hour Time spent sitting down the day of polysomnography is self-reported by patient. Sitting time is in hour and minute.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Specific criteria:

  • Low cervical (< C6), thoracic or lumbar traumatic spinal cord injury (SCI);
  • BMI < 30Kg/m² ;
  • Clinically complete SCI (AIS A) or incomplete with no walking ability;
  • Neurological level;
  • Aged >18 years;
  • Patients with a previous indication for polysomnography as part of routine care and referred to sleep laboratory.

No-specific criteria:

  • Affiliated to the social security system;
  • Absence of serious intercurrent event.

Exclusion Criteria:

Specific criteria:

  • Lower limbs amputation ;
  • Treated OSA;
  • Ongoing diuretic treatment;
  • Pregnant woman;
  • Pacemaker or other (spinal) stimulation equipment.

No-specific criteria:

  • Patient refusal;
  • Patient in a period of exclusion from another protocol;
  • Inability to sign informed consent;
  • Medical or surgical emergency context;
  • Vulnerable person or adult subject to legal protection: pregnant or lactating women, person deprived of their liberty by judicial or administrative decision, person hospitalized without consent, or admitted for purposes other than research, Articles L1121 -5 to L1121-8.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05391308


Contacts
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Contact: Antoine LEOTARD, MD + 33 (0)1.47.10.79.40 antoine.leotard@aphp.fr

Locations
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France
Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Antoine LEOTARD, MD Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05391308    
Other Study ID Numbers: APHP220159
2022-A00105-38 ( Registry Identifier: IDRCB )
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obstructive Sleep Apnea
spinal cord injury
Neck circumference
Neck volume
Fluid shift
Pathophysiology
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Spinal Cord Injuries
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System