Treatment for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lyndhurst Centre, KITE - TRI UHN, Toronto, Canada
Spinal Cord Injuries+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Spinal Cord Injuries
  • Sleep Apnea

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Spinal Cord Injuries. Measurement will happen over the course of Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy.

At completion of the 4-month period of CPAP therapy
Face-to-face, 1-hour interview for qualitative analysis
Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
Depression, Anxiety & Stress Scales- 21
Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy
Epworth Sleepiness Score
Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
Fatigue Severity Scale
Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
Medical Outcomes Study Sleep Scale
Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy
Montreal Cognitive Assessment (MoCA) test

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

This trial requires 24 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in depression, anxiety & stress scales- 21 from baseline to after 4-month period of cpap therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in depression, anxiety & stress scales- 21 from baseline to after 4-month period of cpap therapy for reporting.

Closest Location

Lyndhurst Centre, KITE - TRI UHN - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical warning symptoms and/or signs for SRBDs
English-speaking adults 18 years of age or older
Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
At least 2 months after injury

Patient Q&A Section

What causes sleep apnea?

"About half of sleep apnea cases have an identifiable behavioral or environmental trigger, but there are also other cases for which the cause remains unknown. One of the most important determinants of the extent of the disorder, but one which may be difficult to predict is the length of the airway. A full study of all known variables that may influence the development of obstructive sleep apnea is now required." - Anonymous Online Contributor

Unverified Answer

Can sleep apnea be cured?

"Even though the effect of CPAP use as an adjunct to standard therapy for OSAS is unknown, this therapy may reduce the severity and incidence of OSAS-related complications in patients with OSAS. In addition, patients who achieve good CPAP compliance may experience greater improvements in OSAS severity over time than patients who do not." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep apnea?

"Treatment of sleep apnea is highly dependent on the degree of symptoms experienced. The most common treatments include medication, oxygen therapy, counseling, and lifestyle modification. These treatments, however, are only a fraction of the most successful treatments for OSA." - Anonymous Online Contributor

Unverified Answer

What is sleep apnea?

"Sleep-disordered breathing is common in patients with mild and moderate cognitive impairment. However, when present in an elderly, it may be a marker for another problem such as cognitive impairment." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep apnea?

"Despite a highly prevalent condition, OSA is commonly underdiagnosed in the community. Patients rarely report their symptoms, and often do not seek proper medical attention. Many have not yet had a full workup for OSA." - Anonymous Online Contributor

Unverified Answer

How many people get sleep apnea a year in the United States?

"About 6 million US adults have a severe form of the disorder. These estimates underscore the need for efficient detection and effective clinical management in the United States." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Continuous positive airway pressure is a new and rapidly expanding therapy for treatment of obstructive sleep apnoea especially for patients who have not responded to regular CPAP. It has shown in some studies to achieve better control of sleep apnoea severity than non-CPAP treatment. It is the current standard of care for the treatment of patients with obstructive sleep apnoea. CPAP at lower pressure for longer periods leads to better compliance. The use and duration of CPAP therapy is controversial. The most promising studies are with patient controlled CPAP where the patient is responsible for taking the CPAP at home using a small portable machine the patient carries on their everyday life." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Many people were willing to try different treatment options due to a lack of evidence that one treatment was better than another. Of those willing to try more effective options, the majority prefer to change CPAP pressure rather than change the timing of airway patency. This highlights the importance of choosing a CPAP pressure that will help alleviate [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) during sleep." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Overall, patients with sleep-disordered breathing (SDB) typically receive treatment in combination with other treatments. The findings of this study may highlight the importance of individualized treatment for patients with SDB." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with sleep apnea?

"Although the majority of people report improvement in various QOL measures, very few of those improvements exceed the threshold for statistical significance, indicating a strong possibility of reporting bias in this area. However, some aspects of HRQOL did improve. More work needs to be done in this area to confirm whether these differences are clinically significant." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sleep apnea?

"The mean age of people with sleep apnea is about 60 years. You may get it at a younger age or older; it does not seem to depend on gender, race or height. It seems to be higher in the presence of hypertension, diabetes, high cholesterol, and heart disease." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"In a recent study, findings, treatments were used to address sleep in many different settings, some of which did not correspond to guidelines for treatment. While the number of participants in this study and some of the treatments used may be limitations of this study, it is the first documented report of treatment of sleep problems following MMI, including sleep apnea." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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