Sleep Disordered Breathing (SDB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Clinical Research Initiation Services, University of Miami
ClinicalTrials.gov Identifier:
NCT01467856
First received: September 27, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Sleep Disordered Breathing
Tetraplegia
Procedure: PAP Device Procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing (SDB) in Persons With Chronic Tetraplegia: Characterization and Treatment

Further study details as provided by University of Miami:

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 ]

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Persons with Chronic Spinal Cord Injury who are asymptomatic for acute treable illness.

Criteria

Inclusion Criteria:

  • We 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.
  • We 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.
  • We 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).
  • We 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467856

Locations
United States, Florida
The Miami Project to Cure Paralysis Recruiting
Miami, Florida, United States, 33136
Contact: Kimberly Anderson, Ph.D.    305-243-7108    kanderson3@med.miami.edu   
Contact: Mark s Nash, Ph.D.    305-243-3628    mnash@med.miami.edu   
Sponsors and Collaborators
Clinical Research Initiation Services
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Research Initiation Services, Mark S. Nash, Ph.D., Prinicpal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT01467856     History of Changes
Other Study ID Numbers: TMP-MN-010
Study First Received: September 27, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Tetraplegia

Additional relevant MeSH terms:
Quadriplegia
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Paralysis
Neurologic Manifestations
Nervous System Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on April 21, 2014