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

NCT ID: NCT04007380

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2025-08-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Spinal Cord Injuries Sleep Apnea

Keywords

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Spinal cord injuries Sleep-related breathing disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Continuous positive airway pressure (CPAP) therapy

Intervention Type OTHER

The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs

Interventions

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Continuous positive airway pressure (CPAP) therapy

The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julio Furlan, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

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Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mitsue Aibe, MD

Role: CONTACT

Phone: 4165973422

Email: [email protected]

Julio Furlan, MD

Role: CONTACT

Phone: 4165973422

Email: [email protected]

Facility Contacts

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Mitsue Aibe, MD

Role: primary

Other Identifiers

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19-5072

Identifier Type: -

Identifier Source: org_study_id