NCT05687097

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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.
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.
DEVICE	ECG monitoring	Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2023-01-17
• Last updated: 2024-05-08

Locations

1 site across 1 country: Canada