NCT04007380

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

5.9 years

First QC Date

March 25, 2019

Last Update Submit

December 5, 2024

Conditions

Spinal Cord InjuriesSleep Apnea

Keywords

Spinal cord injuriesSleep-related breathing disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Epworth Sleepiness Score

    Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy

  • Medical Outcomes Study Sleep Scale

    Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy

  • Depression, Anxiety & Stress Scales- 21

    Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy

  • Montreal Cognitive Assessment (MoCA) test

    Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy

Other Outcomes (1)

  • Face-to-face, 1-hour interview for qualitative analysis

    At completion of the 4-month period of CPAP therapy

Study Arms (1)

CPAP-therapy arm

OTHER

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

Interventions

Continuous positive airway pressure (CPAP) therapyOTHER

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

CPAP-therapy arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesSleep Apnea Syndromes

Interventions

Continuous Positive Airway PressureTherapeutics

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementRespiratory Therapy

Study Officials

  • Julio Furlan, MD

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitsue Aibe, MD

CONTACT

4165973422Mitsue.Aibe@uhn.ca

Julio Furlan, MD

CONTACT

4165973422Julio.Furlan@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

July 5, 2019

Study Start

September 27, 2019

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)