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NCT Number: NCT04007380

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

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).

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Key information

Conditions

Spinal Cord Injuries Apnea Central Nervous System Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Mitsue Aibe, MD

CONTACT

[email protected]

416-597-3422 ext. 6285

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julio Furlan, MD

CONTACT

[email protected]

4165973422 ext. 6129

Mitsue Aibe, MD

CONTACT

[email protected]

4165973422 ext. 6285

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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