Clinical trial NCT02176928: Sleep-Disordered Breathing in Chronic SCI
Official title: Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Sleep Apnea, Obstructive
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Wayne State University
First posted: 2014-06-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Investigators will examine the effect of PAP therapy and sleep apnea on thinking (especially memory, learning and concentration), sleep quality, and risks for future heart (cardiovascular) problems in persons with chronic spinal cord injury (SCI).

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.

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.

Primary outcomes:
measure: Cognitive Functioning as Measured by PASAT
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Hospital
state: Florida
city: Miami
country: United States
facility: Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
state: Florida
city: Detroit
country: United States
facility: John D Dingell VA Medical Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine
name: Shirin Shafazand, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.