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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Spine Disease
• Intervention / Treatment: Device: Continuous positive airway pressure (CPAP) therapy

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitsue Aibe, MD; Phone Number: 6285 4165973422; Email: Mitsue.Aibe@uhn.ca
• Study Contact Backup: Name: Abrity Gomes; Phone Number: 6285 4165973422; Email: abrity.gomes@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Recruiting
      • KITE Toronto Research Institute
      • Contact: Mitsue Aibe; Phone Number: 6285 4165973422; Email: Mitsue.Aibe@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early-CPAP therapy group; 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; Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Active Comparator: Delayed-CPAP therapy group; 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; Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
No Intervention: Non-CPAP therapy group; Individuals who are diagnosed with no or mild SRBD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment	The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)	From baseline to 6 months after recruitment
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score 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).	From baseline to 6 months after recruitment
Change in Patient Health Questionnaire (PHQ-9) score 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.	From baseline to 6 months after recruitment
Change in Medical Outcomes Study Sleep Scale (MOS-SS) 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.	From baseline to 6 months after recruitment
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment	The MoCA test scores vary from 0 to 30 (normal).	From baseline to 6 months after recruitment

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Julio C Furlan, MD, FRCPC, KITE Research Institute, University Health Network

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: sleep apnea; sleep-related breathing disorders
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Bone Diseases; Spinal Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 21-6214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The UHN REB needs to approve any plan to share data from this RCT.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No