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出境医 / 临床实验 / Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
Study Description
Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries Sleep Apnea | Other: Continuous positive airway pressure (CPAP) therapy | Not Applicable |
Detailed Description:
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People |
| Actual Study Start Date : | September 27, 2019 |
| Estimated Primary Completion Date : | September 26, 2021 |
| Estimated Study Completion Date : | September 26, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
CPAP-therapy arm
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.
|
Other: Continuous positive airway pressure (CPAP) therapy
The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs
|
Outcome Measures
Primary Outcome Measures :
- Fatigue Severity Scale [ Time Frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy ]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.
Secondary Outcome Measures :
- Epworth Sleepiness Score [ Time Frame: Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy ]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.
- Medical Outcomes Study Sleep Scale [ Time Frame: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy ]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.
- Depression, Anxiety & Stress Scales- 21 [ Time Frame: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy ]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.
- Montreal Cognitive Assessment (MoCA) test [ Time Frame: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy ]Cognitive test administered by an interviewer.
Other Outcome Measures:
- Face-to-face, 1-hour interview for qualitative analysis [ Time Frame: At completion of the 4-month period of CPAP therapy ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Clinical warning symptoms and/or signs for SRBDs
Exclusion Criteria:
- Patients with a non-traumatic spinal cord disease at risk for neurologic progression
- Concomitant diseases of the central nervous system
- Preinjury chronic pain
- Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
- Neuromuscular diseases
- Current substance misuse
- History of primary hypersomnia
- Hypothyroidism
- Moderate or severe iron deficiency anemia
- Active infection
- Kidney failure
- Epilepsy
- Chronic fatigue syndrome
- Vitamin B12 deficiency
Contacts and Locations
Contacts
| Contact: David Houston, MSc | 4165973422 ext 6285 | David.Houston@uhn.ca | |
| Contact: Julio Furlan, MD | 4165973422 ext 6107 | Julio.Furlan@uhn.ca |
Locations
| Canada, Ontario | |
| Lyndhurst Centre, KITE - TRI UHN | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: David Houston, MSc 416-597-3422 ext 6285 David.Houston@uhn.ca | |
Sponsors and Collaborators
University Health Network, Toronto
The Craig H. Neilsen Foundation
Investigators
| Principal Investigator: | Julio Furlan, MD | Toronto Rehabilitation Institute |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 25, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | April 28, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 27, 2019 | ||||||||
| Estimated Primary Completion Date | September 26, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Fatigue Severity Scale [ Time Frame: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy ] 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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Face-to-face, 1-hour interview for qualitative analysis [ Time Frame: At completion of the 4-month period of CPAP therapy ] 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.
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI | ||||||||
| Official Title ICMJE | Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People | ||||||||
| Brief Summary | 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). | ||||||||
| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
|
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| Intervention ICMJE | Other: Continuous positive airway pressure (CPAP) therapy
The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs
|
||||||||
| Study Arms ICMJE | CPAP-therapy arm
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.
Intervention: Other: Continuous positive airway pressure (CPAP) therapy
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
24 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 26, 2021 | ||||||||
| Estimated Primary Completion Date | September 26, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04007380 | ||||||||
| Other Study ID Numbers ICMJE | 19-5072 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Health Network, Toronto | ||||||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||||||
| Collaborators ICMJE | The Craig H. Neilsen Foundation | ||||||||
| Investigators ICMJE |
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| PRS Account | University Health Network, Toronto | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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