Sleep Disordered Breathing

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.

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Tetraplegia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAP Device Procedure

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mark S. Nash, Ph.D., FACSM

Other

Registry information

Official study title

Sleep Disordered Breathing (SDB) in Persons With Chronic Tetraplegia: Characterization and Treatment

Acronym: SDB

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Nov 9, 2011
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed