RecruitingNAINTERVENTIONAL

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI

This research is investigating how using a special breathing machine, called CPAP, can help people with spinal cord injuries who experience breathing difficulties while they sleep. These sleep-related breathing problems, like sleep apnea, are often overlooked but can affect many people with spinal cord injuries, causing tiredness, low mood, and trouble with thinking. The study hopes to find out if regular CPAP use significantly improves these symptoms, as well as their overall well-being, social life, and ability to work. Understanding this link could lead to better ways to support people living with spinal cord injuries.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

27 Sep 2019

Estimated completion

30 Aug 2025

Spinal Cord Injuries Sleep Apnea

What is this study about?

This study is looking into an important health issue that can affect people who have had a spinal cord injury. Many people with a spinal cord injury also experience breathing problems during sleep, often called sleep apnea. This means their breathing repeatedly stops and starts while they're asleep. This can cause them to feel very tired during the day, affect their mood, make it harder to concentrate, and impact their overall quality of life.

While these sleep breathing problems are quite common in the spinal cord injury community, they are often not recognised or treated. This research wants to change that. Researchers believe that using a treatment called CPAP (Continuous Positive Airway Pressure) could make a big difference. CPAP involves wearing a mask over your nose or mouth while you sleep, which gently pushes air to keep your airway open. The study aims to see if using CPAP regularly improves tiredness, sadness, anxiety, thinking skills, and overall quality of life, as well as helping people get more involved in work and social activities.

The findings from this study could be very valuable. By understanding how sleep-related breathing problems are connected to these other difficulties, doctors might be able to offer better support and treatment. Ultimately, this research hopes to improve the daily lives and well-being of people living with spinal cord injuries.

Key takeaways

A study for people with spinal cord injuries and sleep breathing problems.
Investigating CPAP therapy for tiredness, mood, and thinking.
Aims to improve quality of life and social participation.
Participation involves using a CPAP machine for four months.
Findings could lead to better support for people with SCI.

Who may be eligible?

To join this study, you need to be an adult (18 or over) who speaks English, and you must have had a spinal cord injury that affects your neck or chest area (specifically from C5 to T10). Your injury should have happened at least two months ago, and you shouldn't have been diagnosed with a sleep disorder before your injury. You should also have some signs or symptoms that suggest you might have sleep-related breathing problems.

There are also some reasons why you might not be able to join. For example, if you have certain other serious health conditions like some types of brain disorders, uncontrolled chronic pain, specific mental health issues that might make it hard to follow the study's instructions, certain nerve or muscle diseases, or if you're currently misusing substances. You also can't take part if you have kidney failure, epilepsy, severe anaemia, or other specific medical issues like underactive thyroid or chronic fatigue syndrome.

The doctors running the study will carefully check all these points to make sure the study is safe and appropriate for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older and speak English?
Do you have a spinal cord injury in your neck or chest area (C5-T10)?
Did your spinal cord injury happen at least two months ago?
Have you noticed signs or symptoms of breathing problems during sleep?
Are you free from certain other serious health conditions like kidney failure or epilepsy?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of 24 adults. For four months, you'll use a CPAP machine every night to help with your breathing during sleep. Before starting CPAP, you'll have a sleep study, possibly at a hospital or at home, to diagnose your sleep breathing problems. The research team will also be interested in your experiences during this process, so there will likely be discussions or interviews about any challenges you face with the sleep study and starting CPAP therapy.

Potential risks and benefits

Participating in this study might offer potential benefits, such as significant improvement in your fatigue, mood, thinking, and overall quality of life if CPAP therapy is effective for your sleep-related breathing problems. There are also potential risks associated with using CPAP, such as discomfort with the mask or skin irritation, and the time commitment required for the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Lyndhurst Centre, KITE - TRI UHN
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is CPAP therapy?

CPAP therapy uses a machine with a mask worn during sleep to gently deliver air, keeping your airway open and helping you breathe better.

What are 'sleep-related breathing disorders'?

These are conditions like sleep apnea, where your breathing repeatedly stops and starts while you are asleep.

How long does this study last?

If you join, you will use CPAP therapy nightly for four months as part of the study.

Who is running this study?

This study is being led by researchers who are looking into new ways to help people with spinal cord injuries.

Will I have to pay to participate?

Clinical trials generally do not charge participants. Any specific costs or reimbursements will be discussed by the research team.

How to find out more

Mitsue Aibe, MD

mitsue.aibe@uhn.ca 4165973422 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.