Clinical trial NCT05687097: Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Spinal Cord Injuries
Spasticity, Muscle
Neuropathic Pain
Cardiovascular Complication
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Western University
First posted: 2023-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be adults with subacute/chronic, cervical/thoracic, complete/incomplete SCI who were were not previously diagnosed with sleep apnea and under continuous positive airway pressure (CPAP) therapy at the time of the study enrollment and interventions.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: One night of sleep (up to 10 hours)
Secondary outcomes:
measure: Neuropathic pain
timeFrame: Pre-intervention assessment only.
measure: Spasticity
timeFrame: Pre-intervention assessment only.
measure: Cardiovascular dysfunction
timeFrame: Pre-intervention assessment only.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lyndhurst Centre, TRI and KITE Research Institute, UHN
state: Ontario
Study officials:
affiliation: KITE Research Institute, University Health Network
name: Julio Furlan, MD
role: PRINCIPAL_INVESTIGATOR
References: