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Completed

NCT Number: NCT05687097

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

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.

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Key information

Conditions

Sleep Apnea Apnea Cardiovascular Complication Central Nervous System Diseases Dyssomnias Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Spasticity, Muscle Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lyndhurst Centre, TRI and KITE Research Institute, UHN

Toronto, Ontario, M4G 3V9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home-based sleep screening test or hospital-unattended sleep screening test

Device

ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.

Other names: ApneaLink

Cardiovascular beat-to-beat monitoring

Device

CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.

Other names: CareTaker

ECG monitoring

Device

Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.

Other names: Faros Bithium 180

Primary outcomes

  1. Apnea-hypopnea index (AHI)

    Time frame: One night of sleep (up to 10 hours)

    The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device.

Secondary outcomes

  1. Neuropathic pain

    Time frame: Pre-intervention assessment only.

    Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever).

  2. Spasticity

    Time frame: Pre-intervention assessment only.

    Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension).

  3. Cardiovascular dysfunction

    Time frame: Pre-intervention assessment only.

    The number of episodes of autonomic dysreflexia during sleep.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Sunnybrook Health Sciences Centre
  • Western University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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