Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2014-05-31
2018-09-30
Brief Summary
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Detailed Description
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SDB is a condition where there are pauses in breathing or shallow breathing during sleep due to airway narrowing. This leads to low oxygen levels during sleep and sleep disruption. The usual treatment for sleep apnea is PAP (Positive Airway Pressure) worn while sleeping. This involves the use of usually a mask connected to a machine that supplies enough pressure to keep the airway open during sleep.
SDB will be diagnosed in SCI participants using unattended portable level II polysomnography (PSG) (a portable at home sleep study for one night).
Sleep quality (SQ), SDB risk, insomnia severity, daytime sleepiness,and mood will be measured using questionnaires.
Cognitive evaluations will be completed prior to randomization on all participants who also complete a portable PSG to evaluate general and pre-morbid function, immediate verbal memory, simple and sustained attention, processing speed, and executive function.
Blood and urine samples will be taken for participants with SDB diagnosis after randomization.
All randomized subjects will be fitted with a nasal or full-face mask and head gear. PAP will be delivered by an auto-titrating device. These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas, and hypopneas. All subjects will be instructed to use the device nightly during sleep, for the ensuing four months. All outcome measurements will be reassessed after four months of PAP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AutoPAP
PAP treatment will be delivered for four months by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
AutoPAP
PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
AutoPAP treatment 7 nights a week for four months (16 weeks).
Sham PAP
Sham PAP treatment will be delivered for four months by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events.
Sham PAP
Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.
Sham PAP treatment 7 nights a week for four months (16 weeks)./
Interventions
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AutoPAP
PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
AutoPAP treatment 7 nights a week for four months (16 weeks).
Sham PAP
Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.
Sham PAP treatment 7 nights a week for four months (16 weeks)./
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Wayne State University
OTHER
University of Miami
OTHER
Responsible Party
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Shirin Shafazand
Associate Professor of Medicine
Principal Investigators
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Shirin Shafazand, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine
Locations
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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
Countries
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References
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Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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# W81XWH-13-1-0479
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20130161
Identifier Type: -
Identifier Source: org_study_id