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NCT Number: NCT05473689

Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)

This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KITE Toronto Research Institute

Toronto, Ontario, M4G 3V9, Canada

Location status: Recruiting

Location contact

Mitsue Aibe

CONTACT

[email protected]

4165973422 ext. 6285

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)
  • Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
  • Not being treated for sleep apnea prior to the spinal cord impairment onset.

Exclusion criteria

  • Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
  • Concomitant diseases of the central nervous system
  • Preinjury chronic pain
  • Other pre-existing diseases of the central nervous system
  • Significant psychiatric disorders with recent episode of exacerbation
  • Neuromuscular diseases
  • Current substance misuse
  • Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
  • Epilepsy
  • Vitamin B12 deficiency

Treatment and study plan

Continuous positive airway pressure (CPAP) therapy

Device

Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.

Primary outcomes

  1. Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)

  2. Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore

    Time frame: From baseline to 6 months after recruitment

    Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)

  3. Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).

Secondary outcomes

  1. Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)

  2. Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).

  3. Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    The PHQ-9 scores vary from 0 to 27, which means: 0-4 is the normal or minimal; 5-9 if the person is mildly depressed; 10-14 if the person is moderately depressed; 15-19 if the person has moderately severe depression; and 20-27 if the person is severely depressed.

  4. Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.

  5. Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment

    Time frame: From baseline to 6 months after recruitment

    The MoCA test scores vary from 0 to 30 (normal).

Study contacts

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

Lamisa Etu, BSc

CONTACT

[email protected]

4165973422 ext. 6285

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Sunnybrook Health Sciences Centre

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2022
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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