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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Western University | OTHER |
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This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview.
This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview (qualitative analysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals without sleep apnea after spinal cord injury | No significant sleep apnea is defined as an apnea-hypopnea index (AHI) < 5 events per hour of sleep |
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| Individuals with mild sleep apnea after spinal cord injury | Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI <15 events. |
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| Individuals with moderate sleep apnea after spinal cord injury | Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI <15 events. |
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| Individuals with severe sleep apnea after spinal cord injury | Severe sleep apnea is defined as an apnea-hypopnea index (AHI) > 30 events per hour of sleep. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based sleep screening test or hospital-unattended sleep screening test | Device | ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) | The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device. | One night of sleep (up to 10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic pain | Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever). | Pre-intervention assessment only. |
| Spasticity | Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension). |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be adults with subacute/chronic, cervical/thoracic, complete/incomplete SCI who were were not previously diagnosed with sleep apnea and under continuous positive airway pressure (CPAP) therapy at the time of the study enrollment and interventions.
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| Name | Affiliation | Role |
|---|---|---|
| Julio Furlan, MD | KITE Research Institute, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndhurst Centre, TRI and KITE Research Institute, UHN | Toronto | Ontario | M4G 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37130111 | Derived | Furlan JC, Loh E, Boulos MI. The potential effects of untreated sleep-related breathing disorders on neuropathic pain, spasticity, and cardiovascular dysfunction following spinal cord injury: A cross-sectional prospective study protocol. PLoS One. 2023 May 2;18(5):e0282860. doi: 10.1371/journal.pone.0282860. eCollection 2023. |
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Data can be shared with another researcher when UHN REB approval is obtained.
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| Cardiovascular beat-to-beat monitoring | Device | CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep. |
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| ECG monitoring | Device | Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep. |
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| Pre-intervention assessment only. |
| Cardiovascular dysfunction | The number of episodes of autonomic dysreflexia during sleep. | Pre-intervention assessment only. |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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