Sleep Disordered Breathing (SDB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01467856|
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment|
|Sleep Disordered Breathing Tetraplegia||Procedure: PAP Device Procedure|
|Study Type :||Observational|
|Actual Enrollment :||304 participants|
|Official Title:||Sleep Disordered Breathing (SDB) in Persons With Chronic Tetraplegia: Characterization and Treatment|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467856
|United States, Florida|
|The Miami Project to Cure Paralysis|
|Miami, Florida, United States, 33136|