Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
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|ClinicalTrials.gov Identifier: NCT04007380|
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : August 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Sleep Apnea||Other: Continuous positive airway pressure (CPAP) therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
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
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- Moderate or severe iron deficiency anemia
- Active infection
- Kidney failure
- Chronic fatigue syndrome
- Vitamin B12 deficiency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007380
|Contact: Mitsue Aibe, MD||4165973422 ext 6285||Mitsue.Aibe@uhn.ca|
|Contact: Julio Furlan, MD||4165973422 ext 6129||Julio.Furlan@uhn.ca|
|Lyndhurst Centre, KITE - TRI UHN||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Mitsue Aibe, MD 416-597-3422 ext 6285 Mitsue.Aibe@uhn.ca|
|Principal Investigator:||Julio Furlan, MD||Toronto Rehabilitation Institute|
|Responsible Party:||University Health Network, Toronto|
|Other Study ID Numbers:||
|First Posted:||July 5, 2019 Key Record Dates|
|Last Update Posted:||August 17, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal cord injuries
Sleep-related breathing disorders
Sleep Apnea Syndromes
Spinal Cord Injuries
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries