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

May 6, 2024 updated by: Julio Furlan, MD, University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3V9
        • Lyndhurst Centre, TRI and KITE Research Institute, UHN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • ApneaLink
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
  • CareTaker
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
  • Faros Bithium 180
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.
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.
Other Names:
  • ApneaLink
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
  • CareTaker
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
  • Faros Bithium 180
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.
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.
Other Names:
  • ApneaLink
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
  • CareTaker
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
  • Faros Bithium 180
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.
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.
Other Names:
  • ApneaLink
Device: Cardiovascular beat-to-beat monitoring
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
  • CareTaker
Device: ECG monitoring
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
  • Faros Bithium 180

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One night of sleep (up to 10 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pre-intervention assessment only.
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).
Pre-intervention assessment only.
Cardiovascular dysfunction
Time Frame: Pre-intervention assessment only.
The number of episodes of autonomic dysreflexia during sleep.
Pre-intervention assessment only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre
Western University

Investigators

  • Principal Investigator: Julio Furlan, MD, KITE Research Institute, University Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can be shared with another researcher when UHN REB approval is obtained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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