Sleep Disordered Breathing (SDB)
This study has been completed.
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
First received: September 27, 2011
Last updated: July 21, 2014
Last verified: July 2014
Sleep-disordered breathing (SDB) occurs in 2% to 4% of the non-disabled adult population and is characterized by periods of complete breathing cessation (apnea) or marked reductions in airflow (hypopnea) during sleep. By contrast, the diagnosis of SDB affects as many as 83% of persons with tetraplegia within one year of their injury. While some consider daytime somnolescence from poor sleep quality a 'tolerable annoyance', SDB can decrease near-term physical performance and mental alertness, decay memory and intellectual processing, invoke mood disturbances, decrease healthrelated quality of life(HRQoL), and cause vehicular or occupational injury. Recurrent sleep arousal is now strongly associated with cardiometabolic (CM) component risks including insulin resistance, obesity, inflammatory stress, and endothelial dysfunction. Despite considerable advancements in understanding and treating SDB - including favored use of positive airway pressure (PAP) - an evidence base sufficient to warrant routine evaluation and treatment of SDB and related sleep disorders remains elusive for those with spinal cord injury (SCI). To address these knowledge and treatment shortcomings the investigators will conduct a hypothesis-driven study with specific aims that will: 1) describe by stakeholder survey the clinically-relevant determinants of sleep quality in persons with chronic tetraplegia, 2) assess clinical features and co-morbid risks associated with SDB in persons with tetraplegia, and 3) determine in persons with tetraplegia having SDB whether treatment using PAP reduces health risks and improves HRQoL. Hypothesis 1 will be tested using data derived from a website survey.
Sleep Disordered Breathing
Procedure: PAP Device Procedure
||Observational Model: Case-Only
Time Perspective: Prospective
||Sleep Disordered Breathing (SDB) in Persons With Chronic Tetraplegia: Characterization and Treatment
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- To produce an evidence base for customary evaluation and treatment of SDB that will foster changes in medical practice patterns, while bringing attention to both SCI and their health providers of both apparent and obscure hazards of SDB. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Insulin Sensitivity (SI) and Lipid/Inflammation panels: (30 minutes, Taken at Baseline, 1 month, and 3 month time points) SI will be calculated using the Quantitative Insulin Sensitivity Check Index (QUICKI) method177 that requires single fasting blood glucose and insulin values. The same blood sample will be used to assay for a lipid panel containing total cholesterol, LDL, HDL, and triglycerides and an inflammatory panel testing hs-CRP and IL-6.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Procedure: PAP Device Procedure
Following titration, subjects will be issued a PAP machine programmed at this optimum pressure and instructed to use the device nightly for the ensuing three months. Compliance checks will be conducted at months 1 and 3 by having the subjects present the PAP "Smartcard" for download and interpretation.
Daily compliance will be reported as the total number of hours of PAP use per 24 hour period. Patients who use PAP > 4 hours/ night for more than 50% of the nights at one month and 3 month follow-up will be classified as 'compliant' with PAP. Non-compliance will be addressed by a clinical problem-solving approach normally utilized by sleep laboratory personnel in the UM PAP clinic.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Persons with Chronic Spinal Cord Injury who are asymptomatic for acute treable illness.
Blood sampling times will be altered in menstruating women to test during the follicular menstrual phase (cycle days 5-10), as recommended.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467856
|The Miami Project to Cure Paralysis
|Miami, Florida, United States, 33136 |
Mark S. Nash, Ph.D., FACSM
||Mark S. Nash, Ph.D., FACSM, Mark S. Nash, Ph.D., Prinicpal Investigator, University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 27, 2011
||July 21, 2014
||United States: Institutional Review Board
Keywords provided by University of Miami:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 25, 2016
Respiratory Tract Diseases
Nervous System Diseases
Signs and Symptoms