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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMay 8, 2024
May 1, 2024
3.6 years
December 25, 2022
May 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Neuropathic pain
Pre-intervention assessment only.
Spasticity
Pre-intervention assessment only.
Cardiovascular dysfunction
Pre-intervention assessment only.
Study Arms (4)
Individuals without sleep apnea after spinal cord injury
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
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
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
Severe sleep apnea is defined as an apnea-hypopnea index (AHI) \> 30 events per hour of sleep.
Interventions
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Sunnybrook Health Sciences Centrecollaborator
- Western Universitycollaborator
Study Sites (1)
Lyndhurst Centre, TRI and KITE Research Institute, UHN
Toronto, Ontario, M4G 3V9, Canada
Related Publications (1)
Furlan JC, Loh E, Boulos MI. The potential effects of untreated sleep-related breathing disorders on neuropathic pain, spasticity, and cardiovascular dysfunction following spinal cord injury: A cross-sectional prospective study protocol. PLoS One. 2023 May 2;18(5):e0282860. doi: 10.1371/journal.pone.0282860. eCollection 2023.
PMID: 37130111DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Furlan, MD
KITE Research Institute, University Health Network
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Investigator and Scientist
Study Record Dates
First Submitted
December 25, 2022
First Posted
January 17, 2023
Study Start
September 1, 2020
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05