Overnight Upper Airway Infiltration in Spinal Cord Injury

NCT05391308 | Completed

• 2 other identifiers: APHP2201592022-A00105-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea; Spinal Cord Injuries

Keywords

Obstructive Sleep Apnea; spinal cord injury; Neck circumference; Neck volume; Fluid shift; Pathophysiology

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and the overnight change in leg fluid volume (bioelectrical impedance)

  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 Outcomes (1)

• Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck circumference (tape measure)

  18 hours

Other Outcomes (2)

• Tertiary outcome: Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck volume (3D scanner)

  18 hours

• Quaternary outcome: Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and time spent sitting down

  18 hours

Study Arms (1)

Experimental arm

EXPERIMENTAL

All patients will have pre-polysomnographie and post-polysomnographie mesurement.

Other: Pre-polysomnography mesurement; Other: Polysomnography measure; Other: Post-polysomnography measurements

Interventions

Pre-polysomnography mesurement OTHER

Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner), time spent sitting down (self-reporting)

Experimental arm

Polysomnography measure OTHER

Apnea-Hypopnea Index

Experimental arm

Post-polysomnography measurements OTHER

Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner)

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Specific criteria:
• Lower limbs amputation ;
• Treated OSA;
• Ongoing diuretic treatment;
• Pregnant woman;
• Pacemaker or other (spinal) stimulation equipment.
• No-specific criteria:
• Patient refusal;
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP

Garches, 92380, France

Location

Related Publications (12)

• Redolfi S, Yumino D, Ruttanaumpawan P, Yau B, Su MC, Lam J, Bradley TD. Relationship between overnight rostral fluid shift and Obstructive Sleep Apnea in nonobese men. Am J Respir Crit Care Med. 2009 Feb 1;179(3):241-6. doi: 10.1164/rccm.200807-1076OC. Epub 2008 Nov 14.

  PMID: 19011149 BACKGROUND

• Sankari A, Vaughan S, Bascom A, Martin JL, Badr MS. Sleep-Disordered Breathing and Spinal Cord Injury: A State-of-the-Art Review. Chest. 2019 Feb;155(2):438-445. doi: 10.1016/j.chest.2018.10.002. Epub 2018 Oct 12.

  PMID: 30321507 BACKGROUND

• Panza GS, Sutor T, Gee CM, Graco M, McCully KK, Chiodo A, Badr MS, Nash MS; American Congress of Rehabilitation Medicine, Interdisciplinary Special Interest Group, Spinal Cord Injury Physical Function and Wellness Task Force. Is Sleep Disordered Breathing Confounding Rehabilitation Outcomes in Spinal Cord Injury Research? Arch Phys Med Rehabil. 2022 May;103(5):1034-1045. doi: 10.1016/j.apmr.2021.08.015. Epub 2021 Sep 17.

  PMID: 34537222 BACKGROUND

• Bailly S, Grote L, Hedner J, Schiza S, McNicholas WT, Basoglu OK, Lombardi C, Dogas Z, Roisman G, Pataka A, Bonsignore MR, Pepin JL; ESADA Study Group. Clusters of sleep apnoea phenotypes: A large pan-European study from the European Sleep Apnoea Database (ESADA). Respirology. 2021 Apr;26(4):378-387. doi: 10.1111/resp.13969. Epub 2020 Nov 2.

  PMID: 33140467 BACKGROUND

• Proserpio P, Lanza A, Sambusida K, Fratticci L, Frigerio P, Sommariva M, Stagni EG, Redaelli T, De Carli F, Nobili L. Sleep apnea and periodic leg movements in the first year after spinal cord injury. Sleep Med. 2015 Jan;16(1):59-66. doi: 10.1016/j.sleep.2014.07.019. Epub 2014 Oct 7.

  PMID: 25454844 BACKGROUND

• Popa C, Popa F, Grigorean VT, Onose G, Sandu AM, Popescu M, Burnei G, Strambu V, Sinescu C. Vascular dysfunctions following spinal cord injury. J Med Life. 2010 Jul-Sep;3(3):275-85.

  PMID: 20945818 BACKGROUND

• Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

  PMID: 21836140 BACKGROUND

• Murata J, Murata S, Yamagata S, Ohyama M, Kogo H, Umeki N. The attenuating effect of a dynamic cushion on the development of leg edema in wheelchair users with spinal cord injuries. Technol Health Care. 2020;28(4):447-452. doi: 10.3233/THC-192045.

  PMID: 31958103 BACKGROUND

• Viaene A, Roggeman S, Goessaert AS, Kessler TM, Mehnert U, Besien VV, De Muynck M, Everaert K. Conservative treatment for leg oedema and the effect on nocturnal polyuria in patients with spinal cord injury. BJU Int. 2019 May;123(5A):E43-E50. doi: 10.1111/bju.14672. Epub 2019 Feb 6.

  PMID: 30653810 BACKGROUND

• Leotard A, Levy J, Perennou D, Pepin JL, Lofaso F, Bensmail D, Lebret M, Baillieul S. Sleep might have a pivotal role in rehabilitation medicine: A road map for care improvement and clinical research. Ann Phys Rehabil Med. 2021 Jul;64(4):101392. doi: 10.1016/j.rehab.2020.04.006. Epub 2020 Oct 14. No abstract available.

  PMID: 32445976 BACKGROUND

• Berry RB, Brooks R, Gamaldo C, Harding SM, Lloyd RM, Quan SF, Troester MT, Vaughn BV. AASM Scoring Manual Updates for 2017 (Version 2.4). J Clin Sleep Med. 2017 May 15;13(5):665-666. doi: 10.5664/jcsm.6576. No abstract available.

  PMID: 28416048 BACKGROUND

• Kaminska M, Jobin V, Mayer P, Amyot R, Perraton-Brillon M, Bellemare F. The Epworth Sleepiness Scale: self-administration versus administration by the physician, and validation of a French version. Can Respir J. 2010 Mar-Apr;17(2):e27-34. doi: 10.1155/2010/438676.

  PMID: 20422065 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Antoine LEOTARD, MD

  Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 25, 2022
• Study Start: June 1, 2022
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)