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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473689
• Other study ID #: 21-6214
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Mitsue Aibe, MD
• Phone: 4165973422
• Email: Mitsue.Aibe[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Diseases
• Spine Disease

Intervention

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

Locations

Country	Name	City	State
Canada	KITE Toronto Research Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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