Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
NCT ID: NCT05687097
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-09-01
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Western University
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Julio Furlan, MD
Clinical Investigator and Scientist
Principal Investigators
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Julio Furlan, MD
Role: PRINCIPAL_INVESTIGATOR
KITE Research Institute, University Health Network
Locations
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Lyndhurst Centre, TRI and KITE Research Institute, UHN
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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19-5285
Identifier Type: -
Identifier Source: org_study_id
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