Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT01467856
Eligibility Criteria:
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:
1. previous diagnosis of SDB with active use of PAP,
2. inability to read and comprehend English at a grade 5 level,
3. requirement for day or night time non-invasive/invasive mechanical ventilation due to chronic respiratory failure,
4. terminal illness in which life expectancy is less than one year,
5. pregnancy,
6. malignancy,
7. surgery within 6 months,
8. grade 2 or higher pressure ulcer within 3 months,
9. recurrent acute infection or illness requiring hospitalization or IV antibiotics, and
10. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01467856
Study Brief:
Protocol Section:
NCT01467856