Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
2 other identifiers
interventional
93
1 country
1
Brief Summary
- Patients with spinal cord injury (SCI) usually breathe without any mechanical assistance, but significant breathing problems occur often during sleep, either because the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis of the breathing muscles. These problems often go unrecognized, as SCI patients face logistical barriers that cause them to refuse appropriate testing in sleep laboratories. We have devised a strategy for diagnosing sleep-disordered breathing in the patient's home, using placement of noninvasive devices that monitor breathing overnight. This project is designed to test the feasibility and utility of this strategy.
- After collecting baseline data on symptoms and medical events for four months, the home-based studies are performed noninvasively with FDA-approved devices: a type III sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor. If these studies identify sleep-disordered breathing, noninvasive ventilatory support is prescribed according to standard clinical practice. Over the following twelve months, the subjects monitor their symptoms daily, and answer quality-of-life questionnaires every three months. After 3, 6, and 12 months, blood tests are performed to measure blood sugar and cholesterol/lipids. Data is downloaded from the ventilator device to monitor compliance and ventilator performance. This study is designed to determine the prevalence of sleep-disordered breathing in SCI, the feasibility of home-based testing to establish the diagnosis, and the short term effects on symptoms, quality-of-life, and associated conditions (glucose intolerance, blood lipid disorders).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedJanuary 11, 2017
January 1, 2017
4.2 years
June 17, 2013
November 4, 2016
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults
After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.
Month 4 after enrollment
The Frequency of Technical Errors Related to the Home-based Overnight Testing.
All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).
Overnight testing (4-13 hours)
Other Outcomes (4)
Short Term Effects on Daily Symptoms and Medical Events
Months 0-16 after enrollment
Short Term Effects of Noninvasive Ventilatory Support on Quality of Life
Months 4-16
Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism
Months 4-16
- +1 more other outcomes
Study Arms (3)
Normal sleep breathing
NO INTERVENTIONHome-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
BiPAP -Auto for sleep apnea
EXPERIMENTALPatients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
BiPAP (AVAPS) for nocturnal hypoventilation
EXPERIMENTALPatients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.
Interventions
BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.
BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.
Eligibility Criteria
You may qualify if:
- years or older
- C1-T6 spinal cord injury for at least 3 months
- living within 100 miles of Ann Arbor, Michigan, USA
You may not qualify if:
- unable to provide informed consent
- comorbid condition that limits life expectancy to less than 1 year
- ventilator-dependent
- established diagnosis of sleep-disordered breathing
- prior use of noninvasive positive pressure ventilation (CPAP or BiPAP) for any reason (temporary suse of noninvasive ventilation during a hospitalization is permissible if it was discontinued more than 3 months prior to enrollment)
- active duty military personnel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Bauman KA, Kurili A, Schotland HM, Rodriguez GM, Chiodo AE, Sitrin RG. Simplified Approach to Diagnosing Sleep-Disordered Breathing and Nocturnal Hypercapnia in Individuals With Spinal Cord Injury. Arch Phys Med Rehabil. 2016 Mar;97(3):363-71. doi: 10.1016/j.apmr.2015.07.026. Epub 2015 Aug 20.
PMID: 26297810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Although this study demonstrates that home-based overnight testing can identify sleep-disordered breathing in patients with spinal cord injury, it remains an individual clinical decision whether facility-based testing is preferable for some.
Results Point of Contact
- Title
- Robert G. Sitrin, M.D.
- Organization
- University of Michigan Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Robert G Sitrin, Md
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 20, 2013
Study Start
October 1, 2011
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
January 11, 2017
Results First Posted
January 4, 2017
Record last verified: 2017-01