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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04007380
• Other study ID #: 19-5072
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: April 30, 2024

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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 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

• 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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes
• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	Lyndhurst Centre, KITE - TRI UHN	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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