Sleep-Disordered Breathing in Chronic SCI
Completed · Not applicable · Has a placebo group
Conditions studied: Spinal Cord Injury, Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT02176928
- Run by
- University of Miami
- People needed
- 42
- Starts
- 2014-05-01
- Expected to finish
- 2018-09-30
- Last updated by the study team
- 2020-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Miami VA Hospital — Miami, Florida, United States
- Miami Project to Cure Paralysis, University of Miami Miller School of Medicine — Miami, Florida, United States
- John D Dingell VA Medical Center — Detroit, Michigan, United States
- Wayne State University — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.