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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).
SCI is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including SRBDs. The SRBDs include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. Although the frequency of SRBDs after SCI is much greater than in able-bodied people, this condition is still a largely under-recognized in the SCI population.
With this, the investigators hypothesize that regular use of CPAP for treatment of moderate-to-severe SRBDs in individuals living with SCI significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. This research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of CPAP for 4 consecutive months in the management of moderate-to-severe SRBDs among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete SCI; and (ii) a qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy.
Overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with SCI, by examining under-explored links with the SRBDs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP-therapy arm | Other | This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure (CPAP) therapy | Other | The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | Self-reported (or administered by an interviewer) scale where participants choose one of seven levels of agreement for each question. Range from 9 (best outcome) to 63 (worst outcome). The primary outcome is the difference between post-intervention and pre-intervention Fatigue Severity Scales. | Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Score | Self-reported (or administered by an interviewer) where participants answer the 8 brief questions. Range from 0 (best outcome) to 24 (worst outcome). This secondary outcome comprises the difference between post-intervention and pre-intervention Epworth sleepiness scores. | Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Face-to-face, 1-hour interview for qualitative analysis | Qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy. | At completion of the 4-month period of CPAP therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitsue Aibe, MD | Contact | 4165973422 | 6285 | Mitsue.Aibe@uhn.ca |
| Julio Furlan, MD | Contact | 4165973422 | 6129 | Julio.Furlan@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Julio Furlan, MD | Toronto Rehabilitation Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndhurst Centre, KITE - TRI UHN | Recruiting | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D012138 | Respiratory Therapy |
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| Medical Outcomes Study Sleep Scale | Self-reported scale that consists of 12 Likert-type items assessing six dimensions of sleep problems: sleep disturbance (i.e. difficulty initiating or maintaining sleep), snoring, respiratory problems, sleep quantity, sleep adequacy, and daytime somnolence). Higher scores for the domains of sleep disturbance, somnolence and sleep indices indicate worse sleep disturbances, whereas lower scores for sleep quantity and sleep adequacy indicate worse sleep disturbances. | Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy |
| Depression, Anxiety & Stress Scales- 21 | Self-reported (or administered by an interviewer) scale where participants rate questions on depression, anxiety and stress. Depression subscale varies from 0 (best outcome) to 21 (worst outcome). Anxiety subscale varies from 0 (best outcome) to 21 (worst outcome). Stress subscale varies from 0 (best outcome) to 21 (worst outcome). This secondary outcome comprises the difference in the overall pre-intervention and post-intervention DASS-21 scores. | Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy |
| Montreal Cognitive Assessment (MoCA) test | Cognitive test administered by an interviewer. | Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy |
| D014947 | Wounds and Injuries |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |