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

University Health Network, Toronto

Status: Completed

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

Treatments: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05687097

19-5285

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

60 participants in 4 patient groups

Individuals without sleep apnea after spinal cord injury

Description:

No significant sleep apnea is defined as an apnea-hypopnea index (AHI) \< 5 events per hour of sleep

Treatment:

Device: ECG monitoring

Device: Cardiovascular beat-to-beat monitoring

Device: Home-based sleep screening test or hospital-unattended sleep screening test

Individuals with mild sleep apnea after spinal cord injury

Description:

Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI \<15 events.

Treatment:

Device: ECG monitoring

Device: Cardiovascular beat-to-beat monitoring

Device: Home-based sleep screening test or hospital-unattended sleep screening test

Individuals with moderate sleep apnea after spinal cord injury

Description:

Mild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI \<15 events.

Treatment:

Device: ECG monitoring

Device: Cardiovascular beat-to-beat monitoring

Device: Home-based sleep screening test or hospital-unattended sleep screening test

Individuals with severe sleep apnea after spinal cord injury

Description:

Severe sleep apnea is defined as an apnea-hypopnea index (AHI) \> 30 events per hour of sleep.

Treatment:

Device: ECG monitoring

Device: Cardiovascular beat-to-beat monitoring

Device: Home-based sleep screening test or hospital-unattended sleep screening test