Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (qualitative analysis).

Official Title
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Untreated Sleep-related Breathing Disorders as an Aggravating Factor for Neuropathic Pain, Spasticity and Cardiovascular Dysfunction After Spinal Cord Injury: A Cross-sectional Prospective Study

Conditions
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Sleep Apnea, Spinal Cord Injuries, Spasticity, Muscle, Neuropathic Pain, Cardiovascular Complication

Intervention / Treatment
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* Device: Home-based sleep screening test or hospital-unattended sleep screening test
* Device: Cardiovascular beat-to-beat monitoring
* Device: ECG monitoring


Participation Criteria
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Eligibility Criteria
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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); 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals without sleep apnea after spinal cord injury<br>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<br>* ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.<br>* Other names: ApneaLink;Device: Cardiovascular beat-to-beat monitoring<br>* CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.<br>* Other names: CareTaker;Device: ECG monitoring<br>* Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.<br>* Other names: Faros Bithium 180;|
| Individuals with mild sleep apnea after spinal cord injury<br>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<br>* ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.<br>* Other names: ApneaLink;Device: Cardiovascular beat-to-beat monitoring<br>* CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.<br>* Other names: CareTaker;Device: ECG monitoring<br>* Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.<br>* Other names: Faros Bithium 180;|
| Individuals with moderate sleep apnea after spinal cord injury<br>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<br>* ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.<br>* Other names: ApneaLink;Device: Cardiovascular beat-to-beat monitoring<br>* CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.<br>* Other names: CareTaker;Device: ECG monitoring<br>* Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.<br>* Other names: Faros Bithium 180;|
| Individuals with severe sleep apnea after spinal cord injury<br>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<br>* ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.<br>* Other names: ApneaLink;Device: Cardiovascular beat-to-beat monitoring<br>* CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.<br>* Other names: CareTaker;Device: ECG monitoring<br>* Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.<br>* Other names: Faros Bithium 180;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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). | Pre-intervention assessment only. | 
| Cardiovascular dysfunction | The number of episodes of autonomic dysreflexia during sleep. | Pre-intervention assessment only. |