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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687097
• Other study ID #: 19-5285
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Mitsue Aibe, MD
• Phone: 4165973422
• Email: Mitsue.Aibe[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Complication
• Muscle Spasticity
• Neuralgia
• Neuropathic Pain
• Sleep Apnea
• Sleep Apnea Syndromes
• Spasticity, Muscle
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
• ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.

Locations

Country	Name	City	State
Canada	Lyndhurst Centre, TRI and KITE Research Institute, UHN	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre, Western University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Cardiovascular dysfunction	The number of episodes of autonomic dysreflexia during sleep.	Pre-intervention assessment only.