Obstructive Sleep ApneaOUI-SCINCT05391308
Overnight Upper Airway Infiltration in Spinal Cord Injury
A study testing Pre-polysomnography mesurement, Polysomnography measure and Post-polysomnography measurements in people with Obstructive Sleep Apnea and Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Spinal Cord Injuries
- What is being tested?
- Pre-polysomnography mesurement, Polysomnography measure and Post-polysomnography measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- Specific criteria:
- Lower limbs amputation ;
- Treated OSA;
- Ongoing diuretic treatment;
- Pregnant woman;
- Pacemaker or other (spinal) stimulation equipment.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
Garches, 92380
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Spinal Cord Injuries
- Being tested
- Pre-polysomnography mesurement, Polysomnography measure, Post-polysomnography measurements
- Keywords
- Obstructive Sleep Apnea, spinal cord injury, Neck circumference, Neck volume, Fluid shift, Pathophysiology
- Medical subject headings
- Sleep Apnea, Obstructive, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-polysomnography mesurementOther
Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner), time spent sitting down (self-reporting)
Polysomnography measureOther
Apnea-Hypopnea Index
Post-polysomnography measurementsOther
Leg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner)
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All patients will have pre-polysomnographie and post-polysomnographie mesurement. Receives: Other: Pre-polysomnography mesurement; Other: Polysomnography measure; Other: Post-polysomnography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 hours
Secondary outcomes (1)
Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck circumference (tape measure)
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.
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine LEOTARD, MD, Principal investigator, Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391308
- Sponsor's protocol ID
- APHP220159
- Other IDs
- 2022-A00105-38
- Acronym
- OUI-SCI
- Status last verified
- Feb 2025
- First submitted
- 12 May 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19011149Sankari 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.
PubMed 30321507Panza 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.
PubMed 34537222Bailly 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.
PubMed 33140467Proserpio 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.
PubMed 25454844Popa 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.
PubMed 20945818Redolfi 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.
PubMed 21836140Murata 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.
PubMed 31958103Viaene 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.
PubMed 30653810Leotard 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.
PubMed 32445976Berry 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.
PubMed 28416048Kaminska 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.
PubMed 20422065
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Rostral Fluid Shift in the Pathogenesis of Obstructive Sleep Apnea in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT05391308
- Acronym / sponsor ID
- OUI-SCI / APHP220159
- Conditions
- Obstructive Sleep Apnea, Spinal Cord Injuries
- Keywords
- Obstructive Sleep Apnea, spinal cord injury, Neck circumference, Neck volume, Fluid shift, Pathophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Pre-polysomnography mesurement, Other: Polysomnography measure, Other: Post-polysomnography measurementsAll patients will have pre-polysomnographie and post-polysomnographie mesurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- Lower limbs amputation ;
- Treated OSA;
- Ongoing diuretic treatment;
- Pregnant woman;
- Pacemaker or other (spinal) stimulation equipment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-polysomnography mesurementLeg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner), time spent sitting down (self-reporting) | Other | Experimental arm |
| Polysomnography measureApnea-Hypopnea Index | Other | Experimental arm |
| Post-polysomnography measurementsLeg fluid volume (bioelectrical impedance), neck circumference (tape measure), neck volume (3D scanner) | Other | Experimental arm |
Primary outcome
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.
1 secondary outcome
Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and change in neck circumference (tape measure)
Time frame: 18 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 19011149Redolfi 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.
- Background: PubMed 30321507Sankari 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.
- Background: PubMed 34537222Panza 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.
- Background: PubMed 33140467Bailly 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.
- Background: PubMed 25454844Proserpio 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.
- Background: PubMed 20945818Popa 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.
- Background: PubMed 21836140Redolfi 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.
- Background: PubMed 31958103Murata 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.
- Background: PubMed 30653810Viaene 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.
- Background: PubMed 32445976Leotard 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.
- Background: PubMed 28416048Berry 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.
- Background: PubMed 20422065Kaminska 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.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine LEOTARD, MD principal investigator
Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-polysomnography mesurement, Polysomnography measure and Post-polysomnography measurements in people with Obstructive Sleep Apnea and Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between Apnea-Hypopnea Index (polysomnography) and the overnight change in leg fluid volume (bioelectrical impedance) (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391308, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.