Sleep ApneaNCT05687097

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

An observational study of Sleep Apnea and Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnea, Spinal Cord Injuries, Spasticity, Muscle
What is being tested?: Home-based sleep screening test or hospital-unattended sleep screening test, Cardiovascular beat-to-beat monitoring and ECG monitoring
Type of treatment: Medical device
How many people: 60 participants
Where: 1 siteCanada
Study dates: 1 Sep 2020to 31 Mar 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official 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

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.

Read the detailed description

Conditions: Sleep Apnea, Spinal Cord Injuries, Spasticity, Muscle, Neuropathic Pain, Cardiovascular Complication
Being tested: Home-based sleep screening test or hospital-unattended sleep screening test, Cardiovascular beat-to-beat monitoring, ECG monitoring
Medical subject headings: Sleep Apnea Syndromes, Spinal Cord Injuries, Muscle Spasticity, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home-based sleep screening test or hospital-unattended sleep screening testDevice
Also called ApneaLink
ApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.
Cardiovascular beat-to-beat monitoringDevice
Also called CareTaker
CareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.
ECG monitoringDevice
Also called Faros Bithium 180
Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.

Study groups in NCT05687097
Study group	Role	What they receive
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 Receives: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring
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. Receives: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring
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. Receives: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring
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. Receives: Device: Home-based sleep screening test or hospital-unattended sleep screening test; Device: Cardiovascular beat-to-beat monitoring; Device: ECG monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnea-hypopnea index (AHI)
The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device.
Measured: One night of sleep (up to 10 hours)

Secondary outcomes (3)

Neuropathic pain
Level of neuropathic pain prior to the interventions using Visual Analog Scale (0: no pain; 100: the worst pain ever).
Measured: Pre-intervention assessment only.
Spasticity
Degree of spasticity prior to the interventions using the modified Ashworth Scale (0: normal tone; 16: all four extremities rigid in flexion or extension).
Measured: Pre-intervention assessment only.
Cardiovascular dysfunction
The number of episodes of autonomic dysreflexia during sleep.
Measured: Pre-intervention assessment only.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202031 Mar 2024

First posted17 Jan 2023
Study start1 Sep 2020
Primary completion31 Mar 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05687097
Sponsor's protocol ID: 19-5285
Status last verified: May 2024
First submitted: 25 Dec 2022
Last updated: 8 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Data can be shared with another researcher when UHN REB approval is obtained.

Publications

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.
PubMed 37130111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05687097
Acronym / sponsor ID: 19-5285
Conditions: Sleep Apnea, Spinal Cord Injuries, Spasticity, Muscle, Neuropathic Pain, Cardiovascular Complication
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: Sunnybrook Health Sciences Centre, Western University
Study start: 1 Sep 2020 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 17 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Individuals without sleep apnea after spinal cord injury	–	Device: Home-based sleep screening test or hospital-unattended sleep screening test, Device: Cardiovascular beat-to-beat monitoring, Device: ECG monitoringNo significant sleep apnea is defined as an apnea-hypopnea index (AHI) < 5 events per hour of sleep
Individuals with mild sleep apnea after spinal cord injury	–	Device: Home-based sleep screening test or hospital-unattended sleep screening test, Device: Cardiovascular beat-to-beat monitoring, Device: ECG monitoringMild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep, but an AHI <15 events.
Individuals with moderate sleep apnea after spinal cord injury	–	Device: Home-based sleep screening test or hospital-unattended sleep screening test, Device: Cardiovascular beat-to-beat monitoring, Device: ECG monitoringMild sleep apnea is defined as an apnea-hypopnea index (AHI) ≥ 5 events per hour of sleep but an AHI <15 events.
Individuals with severe sleep apnea after spinal cord injury	–	Device: Home-based sleep screening test or hospital-unattended sleep screening test, Device: Cardiovascular beat-to-beat monitoring, Device: ECG monitoringSevere sleep apnea is defined as an apnea-hypopnea index (AHI) > 30 events per hour of sleep.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Home-based sleep screening test or hospital-unattended sleep screening testAlso: ApneaLinkApneaLink device will be used to assess the number of apnea and hypopnea events per hour of sleep.	Device	Individuals with mild sleep apnea after spinal cord injury, Individuals with moderate sleep apnea after spinal cord injury, Individuals with severe sleep apnea after spinal cord injury, Individuals without sleep apnea after spinal cord injury
Cardiovascular beat-to-beat monitoringAlso: CareTakerCareTaker device will be used to continuously record the participant's arterial blood pressure and heart rate during sleep.	Device	Individuals with mild sleep apnea after spinal cord injury, Individuals with moderate sleep apnea after spinal cord injury, Individuals with severe sleep apnea after spinal cord injury, Individuals without sleep apnea after spinal cord injury
ECG monitoringAlso: Faros Bithium 180Faror Bithium 180 device will be used to continuously record the participant's ECG during sleep.	Device	Individuals with mild sleep apnea after spinal cord injury, Individuals with moderate sleep apnea after spinal cord injury, Individuals with severe sleep apnea after spinal cord injury, Individuals without sleep apnea after spinal cord injury

Primary outcome

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.

3 secondary outcomes

Neuropathic pain
Time frame: Pre-intervention assessment only.
Spasticity
Time frame: Pre-intervention assessment only.
Cardiovascular dysfunction
Time frame: Pre-intervention assessment only.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Derived from this study: PubMed 37130111Furlan 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.
Individual participant dataSharing planned: Undecided. Data can be shared with another researcher when UHN REB approval is obtained.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julio Furlan, MD principal investigator

KITE Research Institute, University Health Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea and Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-hypopnea index (AHI) (time frame: One night of sleep (up to 10 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.