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

Completed

• Conditions: Sleep Apnea; Spinal Cord Injuries; Spasticity, Muscle; Neuropathic Pain; Cardiovascular Complication
• Interventions: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring

• Registration Number: NCT05687097
• Lead Sponsor: University Health Network, Toronto

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.

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-17
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals without sleep apnea after spinal cord injury	Home-based sleep screening test or hospital-unattended sleep screening test	No significant sleep apnea is defined as an apnea-hypopnea index (AHI) \< 5 events per hour of sleep
Individuals with mild sleep apnea after spinal cord injury	ECG monitoring	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI \<15 events.
Individuals with moderate sleep apnea after spinal cord injury	ECG monitoring	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI \<15 events.
Individuals with severe sleep apnea after spinal cord injury	Home-based sleep screening test or hospital-unattended sleep screening test	Severe sleep apnea is defined as an apnea-hypopnea index (AHI) \> 30 events per hour of sleep.
Individuals with severe sleep apnea after spinal cord injury	Cardiovascular beat-to-beat monitoring	Severe sleep apnea is defined as an apnea-hypopnea index (AHI) \> 30 events per hour of sleep.
Individuals without sleep apnea after spinal cord injury	Cardiovascular beat-to-beat monitoring	No significant sleep apnea is defined as an apnea-hypopnea index (AHI) \< 5 events per hour of sleep
Individuals without sleep apnea after spinal cord injury	ECG monitoring	No significant sleep apnea is defined as an apnea-hypopnea index (AHI) \< 5 events per hour of sleep
Individuals with mild sleep apnea after spinal cord injury	Home-based sleep screening test or hospital-unattended sleep screening test	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI \<15 events.
Individuals with mild sleep apnea after spinal cord injury	Cardiovascular beat-to-beat monitoring	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI \<15 events.
Individuals with moderate sleep apnea after spinal cord injury	Home-based sleep screening test or hospital-unattended sleep screening test	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI \<15 events.
Individuals with moderate sleep apnea after spinal cord injury	Cardiovascular beat-to-beat monitoring	Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI \<15 events.
Individuals with severe sleep apnea after spinal cord injury	ECG monitoring	Severe sleep apnea is defined as an apnea-hypopnea index (AHI) \> 30 events per hour of sleep.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Cardiovascular dysfunction	Pre-intervention assessment only.	The number of episodes of autonomic dysreflexia during sleep.
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).

Trial Locations

Locations (1)

Lyndhurst Centre, TRI and KITE Research Institute, UHN; 🇨🇦 Toronto, Ontario, Canada