search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Spine Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP) therapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring sleep apnea, sleep-related breathing disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KITE Toronto Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Early-CPAP therapy group

Delayed-CPAP therapy group

Non-CPAP therapy group

Arm Description

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

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

Individuals who are diagnosed with no or mild SRBD.

Outcomes

Primary Outcome Measures

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)
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)
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).

Secondary Outcome Measures

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)
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).
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.
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.
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).

Full Information

First Posted
July 19, 2022
Last Updated
October 10, 2023
Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT05473689
Brief Title
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Official Title
Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spine Disease
Keywords
sleep apnea, sleep-related breathing disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early-CPAP therapy group
Arm Type
Experimental
Arm Description
Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.
Arm Title
Delayed-CPAP therapy group
Arm Type
Active Comparator
Arm Description
Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.
Arm Title
Non-CPAP therapy group
Arm Type
No Intervention
Arm Description
Individuals who are diagnosed with no or mild SRBD.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP) therapy
Intervention Description
Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.
Primary Outcome Measure Information:
Title
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
Description
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
Time Frame
From baseline to 6 months after recruitment
Title
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
Description
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Time Frame
From baseline to 6 months after recruitment
Title
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
Description
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).
Time Frame
From baseline to 6 months after recruitment
Secondary Outcome Measure Information:
Title
Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment
Description
The FSS scores vary from 9 (normal) to 56 (the most severe degree of fatigue)
Time Frame
From baseline to 6 months after recruitment
Title
Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment
Description
The DASS-21 scores vary from 0 (normal) to 42 (most severe symptoms of depression, anxiety and stress).
Time Frame
From baseline to 6 months after recruitment
Title
Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment
Description
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.
Time Frame
From baseline to 6 months after recruitment
Title
Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment
Description
Scores for the sleep disturbance, snoring, respiratory problems, sleep adequacy, and daytime somnolence dimensions range from 0 (normal) to 100.
Time Frame
From baseline to 6 months after recruitment
Title
Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment
Description
The MoCA test scores vary from 0 to 30 (normal).
Time Frame
From baseline to 6 months after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitsue Aibe, MD
Phone
4165973422
Ext
6285
Email
Mitsue.Aibe@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mersida Poloska
Phone
4165973422
Ext
6285
Email
mersida.poloska@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio C Furlan, MD, FRCPC
Organizational Affiliation
KITE Research Institute, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
KITE Toronto Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsue Aibe
Phone
4165973422
Ext
6285
Email
Mitsue.Aibe@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The UHN REB needs to approve any plan to share data from this RCT.

Learn more about this trial

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

We'll reach out to this number within 24 hrs