Sleep Apnea, Obstructive, Spinal Cord Injury
Conditions
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.
Interventions
DEVICEAutoPAP
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).
DEVICESham 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)./
Sponsors
United States Department of Defense
Wayne State University
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functioning as Measured by PASAT | 16 weeks | Paced Serial Addition Test (PASAT) measures divided attention and memory. PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 21 |
| 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)./ | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Sham PAP | Total | AutoPAP |
|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 14.3 | 44.2 years STANDARD_DEVIATION 12.4 | 41.5 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 23 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 18 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 29 Participants | 16 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 18 Participants | 36 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Cognitive Functioning as Measured by PASAT
Paced Serial Addition Test (PASAT) measures divided attention and memory. PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention.
Time frame: 16 weeks
Population: 2 sham participants did not complete PASAT at 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AutoPAP | Cognitive Functioning as Measured by PASAT | 10.6 score on a scale | Standard Deviation 7.6 |
| Sham PAP | Cognitive Functioning as Measured by PASAT | 15.2 score on a scale | Standard Deviation 10.4 |