Status:
COMPLETED
Sleep Disordered Breathing
Lead Sponsor:
Mark S. Nash, Ph.D., FACSM
Conditions:
Sleep Disordered Breathing
Tetraplegia
Eligibility:
All Genders
18-65 years
Brief Summary
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 (hypopn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01467856
Start Date
October 1 2010
End Date
October 1 2013
Last Update
February 17 2017
Active Locations (1)
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1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136