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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007380
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : August 17, 2022
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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
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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 : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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:
  1. 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
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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
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Information from the National Library of Medicine

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


Contacts
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Contact: Mitsue Aibe, MD 4165973422 ext 6285 Mitsue.Aibe@uhn.ca
Contact: Julio Furlan, MD 4165973422 ext 6129 Julio.Furlan@uhn.ca

Locations
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Canada, Ontario
Lyndhurst Centre, KITE - TRI UHN Recruiting
Toronto, Ontario, Canada
Contact: Mitsue Aibe, MD    416-597-3422 ext 6285    Mitsue.Aibe@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: Julio Furlan, MD Toronto Rehabilitation Institute
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04007380    
Other Study ID Numbers: 19-5072
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Spinal cord injuries
Sleep-related breathing disorders
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Spinal Cord Injuries
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries