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

January 30, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Overnight Rostral Fluid Shift in the Pathogenesis of Obstructive Sleep Apnea in Spinal Cord Injured Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Garches, France, 92380
        • Recruiting
        • Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 hours
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.
18 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Antoine LEOTARD, MD, Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220159
  • 2022-A00105-38 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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