- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05687097
Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
March 25, 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
Recruiting
Conditions
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 (Estimated)
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
- Name: Mitsue Aibe, MD
- Phone Number: 6285 4165973422
- Email: Mitsue.Aibe@uhn.ca
Study Contact Backup
- Name: Abrity Gomes
- Phone Number: 6285 4165973422
- Email: abrity.gomes@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4G 3V9
- Recruiting
- Lyndhurst Centre, TRI and KITE Research Institute, UHN
-
Contact:
- Mistue Aibe, MD
- Phone Number: 6285 4165973422
- Email: Mitsue.Aibe@uhn.ca
-
Principal Investigator:
- Julio Furlan, MD
-
Contact:
- Abrity Gomes
- Phone Number: Furlan 4165973422
- Email: Abrity.Gomes@uhn.ca
-
-
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
|
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
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.
|
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
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.
|
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
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.
|
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Other Names:
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
Other Names:
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.
Other Names:
|
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.
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 (Estimated)
March 31, 2024
Study Completion (Estimated)
April 30, 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)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuromuscular Manifestations
- Trauma, Nervous System
- Spinal Cord Diseases
- Muscle Hypertonia
- Sleep Apnea Syndromes
- Neuralgia
- Wounds and Injuries
- Spinal Cord Injuries
- Muscle Spasticity
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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