Status:
COMPLETED
Overnight Upper Airway Infiltration in Spinal Cord Injury
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obstructive Sleep Apnea
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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, ...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05391308
Start Date
June 1 2022
End Date
May 27 2024
Last Update
March 3 2025
Active Locations (1)
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1
Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP
Garches, France, 92380