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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sunnybrook Health Sciences Centre
Western University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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