Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Device: Home-based sleep screening test or hospital-unattended sleep screening test
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
| 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. |
Device: Home-based sleep screening test or hospital-unattended sleep screening test
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
| 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. |
Device: Home-based sleep screening test or hospital-unattended sleep screening test
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
| 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. |
Device: Home-based sleep screening test or hospital-unattended sleep screening test
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Apnea-hypopnea index (AHI) [One night of sleep (up to 10 hours)]
The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device.
Secondary Outcome Measures
- Neuropathic pain [Pre-intervention assessment only.]
Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever).
- Spasticity [Pre-intervention assessment only.]
Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension).
- Cardiovascular dysfunction [Pre-intervention assessment only.]
The number of episodes of autonomic dysreflexia during sleep.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Individuals with subacute/chronic (> 1 month after injury) spinal cord injury.
-
Individuals with a mid-cervical/mid-thoracic (levels C5 to T6) spinal cord injury.
-
Individuals with a complete or incomplete (ASIA Impairment Scale A, B, C, or D) spinal cord injury.
Exclusion Criteria:
-
individuals with other disorders of the central nervous system (e.g., sequelae of traumatic brain injury, stroke);
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Individuals with psychiatric disorders that can interfere with adherence to study;
-
Individuals with neuromuscular diseases;
-
Individuals with history of substance abuse;
-
Individuals with prior history of hypersomnias or sleep apnea under treatment;
-
Individuals with prior history of chronic pain (e.g. fibromyalgia).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lyndhurst Centre, TRI and KITE Research Institute, UHN | Toronto | Ontario | Canada | M4G 3V9 |
Sponsors and Collaborators
- University Health Network, Toronto
- Sunnybrook Health Sciences Centre
- Western University
Investigators
- Principal Investigator: Julio Furlan, MD, KITE Research Institute, University Health Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-5285