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N/A N=42 Randomized Triple-blind Treatment

Sleep-Disordered Breathing in Chronic SCI

Spinal Cord Injury · Sleep Apnea, Obstructive

Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Cognitive Functioning as Measured by PASAT — 10.6; 15.2 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AutoPAP (Device); Sham PAP (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Miami
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Cognitive Functioning as Measured by PASAT
10.6; 15.2

Summary

The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality, health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate measures in persons with chronic SCI.

Eligibility Criteria

Inclusion Criteria

  • Chronic tetraplegia or paraplegia (C4-L1)
  • American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D
  • 18 years and older
  • At least one year post injury
  • Hearing and vision suitable for comprehension of instructions, and perception of cognitive test stimuli
  • No color blindness as measured by a brief screen with color perception Ishihara cards
  • Stable medical condition for 2 weeks prior to enrollment. Patients admitted to hospital will be eligible for enrolment if the acute illness precipitating admission is in recovery phase for 2 weeks or longer

Exclusion Criteria

  • Diagnosis of SDB and successful positive airway pressure (PAP) therapy prior to injury. Those with a diagnosis of SDB post injury who are not receiving therapy for SDB (PAP, surgical, and/or oral appliance) are eligible for study enrollment
  • Patients who are intubated, have a tracheostomy, and/or are using long term invasive/non-invasive positive pressure ventilation
  • Participants with predominant central sleep apnea on PSG requiring bi-level PAP therapy
  • Severe traumatic brain injury (GCS < 8 at first assessment)
  • Unable to understand or read English at a grade 5 level
  • Inability to provide informed consent
  • Evidence of advanced neurological or systemic disease that may affect cognitive functioning (e.g., Alzheimer's disease, Dementia, Parkinson's disease)
  • Significant aphasia or language impairments
  • Positive airway pressure therapy may be contraindicated in some patients with the following preexisting conditions:
  • severe bullous lung disease
  • pneumothorax
  • pathologically low blood pressure
  • dehydration
  • cerebrospinal fluid leak, recent cranial surgery, or trauma.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02176928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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