An interventional study of AutoPAP and Sham PAP in Spinal Cord Injury and Sleep Apnea, Obstructive, sponsored by University of Miami. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's enrollment of 42 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: AutoPAP
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.
Device: Sham PAP
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).
Also known as: IntelliPAP AutoAdjust®, CPAP
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)./
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
| Milestone | AutoPAP | Sham PAP |
|---|---|---|
| Started | 21 | 21 |
| Completed | 19 | 17 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 2 | 4 |
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.
| score on a scale | AutoPAP | Sham PAP |
|---|---|---|
| Cognitive Functioning as Measured by PASAT | 10.6 ± 7.6 | 15.2 ± 10.4 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AutoPAP | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Sham PAP | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | AutoPAP | Sham PAP | Total |
|---|---|---|---|
| Mean | 41.5 ± 9.6 | 46.9 ± 14.3 | 44.2 ± 12.4 |
| Sex: Female, Male(Participants) | AutoPAP | Sham PAP | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 18 | 18 | 36 |
| Ethnicity (NIH/OMB)(Participants) | AutoPAP | Sham PAP | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 6 | 23 |
| Not Hispanic or Latino | 4 | 14 | 18 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | AutoPAP | Sham PAP | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 6 | 7 |
| White | 16 | 13 | 29 |
| More than one race | 4 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
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