Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People

This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea; Spinal Cord Injuries
• Intervention / Treatment: Other: Continuous positive airway pressure (CPAP) therapy

Detailed Description

SCI is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including SRBDs. The SRBDs include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. Although the frequency of SRBDs after SCI is much greater than in able-bodied people, this condition is still a largely under-recognized in the SCI population.

With this, the investigators hypothesize that regular use of CPAP for treatment of moderate-to-severe SRBDs in individuals living with SCI significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. This research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of CPAP for 4 consecutive months in the management of moderate-to-severe SRBDs among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete SCI; and (ii) a qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy.

Overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with SCI, by examining under-explored links with the SRBDs.

• Study Type: Interventional
• Enrollment (Estimated): 24
• 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: Julio Furlan, MD; Phone Number: 6129 4165973422; Email: Julio.Furlan@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Lyndhurst Centre, KITE - TRI UHN
      • Contact: Mitsue Aibe, MD; Phone Number: 6285 416-597-3422; 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
• Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
• At least 2 months after injury
• Clinical warning symptoms and/or signs for SRBDs

Exclusion Criteria:

• Patients with a non-traumatic spinal cord disease at risk for neurologic progression
• Concomitant diseases of the central nervous system
• Preinjury chronic pain
• Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
• Neuromuscular diseases
• Current substance misuse
• History of primary hypersomnia
• Hypothyroidism
• Moderate or severe iron deficiency anemia
• Active infection
• Kidney failure
• Epilepsy
• Chronic fatigue syndrome
• Vitamin B12 deficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CPAP-therapy arm; This single-arm clinical trial will examine the effects of 4-month period CPAP therapy in individuals living with SCI. The CPAP will be adjusted according to the results of the auto-titrating CPAP testing for each participant.	Other: Continuous positive airway pressure (CPAP) therapy; The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale	Self-reported (or administered by an interviewer) scale where participants choose one of seven levels of agreement for each question. Range from 9 (best outcome) to 63 (worst outcome). The primary outcome is the difference between post-intervention and pre-intervention Fatigue Severity Scales.	Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Score	Self-reported (or administered by an interviewer) where participants answer the 8 brief questions. Range from 0 (best outcome) to 24 (worst outcome). This secondary outcome comprises the difference between post-intervention and pre-intervention Epworth sleepiness scores.	Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy
Medical Outcomes Study Sleep Scale	Self-reported scale that consists of 12 Likert-type items assessing six dimensions of sleep problems: sleep disturbance (i.e. difficulty initiating or maintaining sleep), snoring, respiratory problems, sleep quantity, sleep adequacy, and daytime somnolence). Higher scores for the domains of sleep disturbance, somnolence and sleep indices indicate worse sleep disturbances, whereas lower scores for sleep quantity and sleep adequacy indicate worse sleep disturbances.	Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy
Depression, Anxiety & Stress Scales- 21	Self-reported (or administered by an interviewer) scale where participants rate questions on depression, anxiety and stress. Depression subscale varies from 0 (best outcome) to 21 (worst outcome). Anxiety subscale varies from 0 (best outcome) to 21 (worst outcome). Stress subscale varies from 0 (best outcome) to 21 (worst outcome). This secondary outcome comprises the difference in the overall pre-intervention and post-intervention DASS-21 scores.	Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy
Montreal Cognitive Assessment (MoCA) test	Cognitive test administered by an interviewer.	Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face-to-face, 1-hour interview for qualitative analysis	Qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy.	At completion of the 4-month period of CPAP therapy

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Julio Furlan, MD, Toronto Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Sleep-related breathing disorders; Spinal cord injuries
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Sleep Apnea Syndromes; Spinal Cord Injuries
• Other Study ID Numbers: 19-5072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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