Sleep Disordered Breathing (SDB)
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ClinicalTrials.gov Identifier: NCT01467856 |
Recruitment Status
:
Completed
First Posted
: November 9, 2011
Last Update Posted
: February 17, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Sleep Disordered Breathing Tetraplegia | Procedure: PAP Device Procedure |
Study Type : | Observational |
Actual Enrollment : | 304 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Group/Cohort | Intervention/treatment |
---|---|
chronic tetraplegia |
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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- The investigators will consecutively enroll 500 persons with chronic SCI (NParaplegia =250, NTetraplegia =250) in a web-based survey.
- Study participants will include males and females aged 18 years and older with SCI at the C5-L1 levels for more than 1 year.
- The investigators will consecutively enroll 75 persons with chronic tetraplegia aged 18 years and older with SCI at the C5-C8 levels for more than one year.
- The International Standards for Neurological Classification of SCI (ASIA/ISCoS)157 will serve as benchmarks for subject classification.
- A rater experienced in these procedures will classify study subjects.
- Persons from all ethnic and racial groups will be enrolled.
-
The investigators will seek a gender distribution in proportion to population representation of persons with SCI (~80% male,
~20% female).
- After being provided with the study privacy practices, and HIPAA certification indicating available protections, participant candidates will undergo informed consent procedures approved by the Human Subjects Committee (IRB) at the University of Miami Miller School of Medicine (UM-MSOM).
- The investigators will consecutively enroll the first 25 persons from testing under Specific Aim 2 who satisfy criteria for diagnosis of SDB and consent to undergo additional study.
Exclusion Criteria:
-
Subject candidates will be excluded for:
- previous diagnosis of SDB with active use of PAP,
- inability to read and comprehend English at a grade 5 level,
- requirement for day or night time non-invasive/invasive mechanical ventilation due to chronic respiratory failure,
- terminal illness in which life expectancy is less than one year,
- pregnancy,
- malignancy,
- surgery within 6 months,
- grade 2 or higher pressure ulcer within 3 months,
- recurrent acute infection or illness requiring hospitalization or IV antibiotics, and
- previous MI or cardiac surgery. The following medications and drug therapies will disqualify subjects from participating due to influences on lipids/lipoproteins, glucose/insulin, and inflammatory markers:
- lipid altering agents,
- β-adrenergic antagonists,
- maintenance α-blockers,
- insulin-sensitizers, and
- maintenance aspirin and
- non-steroidal anti-inflammatory drugs.
Blood sampling times will be altered in menstruating women to test during the follicular menstrual phase (cycle days 5-10), as recommended.

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 |
Additional Information:
Responsible Party: | Mark S. Nash, Ph.D., FACSM, Mark S. Nash, Ph.D., Prinicpal Investigator, University of Miami |
ClinicalTrials.gov Identifier: | NCT01467856 History of Changes |
Other Study ID Numbers: |
TMP-MN-010 |
First Posted: | November 9, 2011 Key Record Dates |
Last Update Posted: | February 17, 2017 |
Last Verified: | February 2017 |
Keywords provided by Mark S. Nash, Ph.D., FACSM, University of Miami:
Tetraplegia |
Additional relevant MeSH terms:
Respiratory Aspiration Quadriplegia Respiration Disorders Respiratory Tract Diseases Pathologic Processes |
Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |