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

NCT05473689 | Recruiting

• 1 other identifier: 21-6214
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Spine Disease

Keywords

sleep apnea; sleep-related breathing disorders

Outcome Measures

Primary Outcomes (3)

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

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

  From baseline to 6 months after recruitment

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

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

  From baseline to 6 months after recruitment

• Change in Spinal Cord Independence Measure (SCIM) - version III - score 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).

  From baseline to 6 months after recruitment

Secondary Outcomes (5)

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

  From baseline to 6 months after recruitment

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

  From baseline to 6 months after recruitment

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

  From baseline to 6 months after recruitment

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

  From baseline to 6 months after recruitment

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

  From baseline to 6 months after recruitment

Study Arms (3)

Early-CPAP therapy group

EXPERIMENTAL

Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.

Device: Continuous positive airway pressure (CPAP) therapy

Delayed-CPAP therapy group

ACTIVE COMPARATOR

Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.

Device: Continuous positive airway pressure (CPAP) therapy

Non-CPAP therapy group

NO INTERVENTION

Individuals who are diagnosed with no or mild SRBD.

Interventions

Continuous positive airway pressure (CPAP) therapy DEVICE

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

Delayed-CPAP therapy group; Early-CPAP therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

KITE Toronto Research Institute

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

Related Publications (1)

• Furlan JC, Yao C, McKay M, Walsh S, Boulos M. Study protocol for the Outcomes Post-Treatment: Impact on Motor Impairment of Sleep Efficiency in Spinal Cord Injury (OPTIMISE SCI) - a randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e099266. doi: 10.1136/bmjopen-2025-099266.

  PMID: 40480676 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Diseases; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Julio C Furlan, MD, FRCPC

  KITE Research Institute, University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamisa Etu, BSc

CONTACT

4165973422; LamisaFaria.Etu@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: August 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)