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Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882257
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : January 4, 2017
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Robert G. Sitrin, M.D., University of Michigan

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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Hypercapnia Spinal Cord Injury Device: BiPAP Device: BiPAP/AVAPS (Phillips Respironics) Not Applicable

Detailed Description:

Eligible subjects will sign informed consent, followed by:

a 4 month period of maintaining a daily log of symptoms and medical events (such as hospitalization, starting antibiotics).

An overnight sleep study will be performed in the subject's home Based on the results of the sleep study, noninvasive ventilation (BiPAP) will be prescribed, according to standard medical practice. A clinical assessment, pulmonary function tests, and blood tests (blood glucose, hemoglobin A1C, and blood lipid profile) will be performed at the same time.

Quality of life surveys will be performed at months 0, 3, 6, and 12. The daily symptom logs will be continued for 12 months. Data from the BiPAP units will be downloaded and repeat overnight monitoring to measure blood oxygen and carbon dioxide levels will be performed periodically for 12 months after BiPAP is started.

Subjects without sleep-disordered breathing will have the same clinical assessments and blood tests as subjects for whom BiPAP has been described.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
Study Start Date : October 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Normal sleep breathing
Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
Experimental: BiPAP -Auto for sleep apnea
Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.
Device: BiPAP
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.
Other Name: BiPAP-auto (Phillips Respironics)

Experimental: BiPAP (AVAPS) for nocturnal hypoventilation
Patients 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.
Device: BiPAP/AVAPS (Phillips Respironics)
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.

Primary Outcome Measures :
  1. Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults [ Time Frame: Month 4 after enrollment ]
    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.

  2. The Frequency of Technical Errors Related to the Home-based Overnight Testing. [ Time Frame: Overnight testing (4-13 hours) ]
    All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).

Other Outcome Measures:
  1. Short Term Effects on Daily Symptoms and Medical Events [ Time Frame: Months 0-16 after enrollment ]
    The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period

  2. Short Term Effects of Noninvasive Ventilatory Support on Quality of Life [ Time Frame: Months 4-16 ]
    At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.

  3. Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism [ Time Frame: Months 4-16 ]
    When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels

  4. Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing [ Time Frame: Month 4 after enrollment ]
    Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older
  • C1-T6 spinal cord injury for at least 3 months
  • living within 100 miles of Ann Arbor, Michigan, USA

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882257

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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Robert G Sitrin, Md University of Michigan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert G. Sitrin, M.D., Professor of Internal Medicine, University of Michigan Identifier: NCT01882257    
Other Study ID Numbers: HUM00051504
W81XWH-11-1-0826 ( Other Grant/Funding Number: Department of Defense )
First Posted: June 20, 2013    Key Record Dates
Results First Posted: January 4, 2017
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Robert G. Sitrin, M.D., University of Michigan:
obstructive sleep apnea
sleep-disordered breathing
spinal cord injury
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Aspiration
Spinal Cord Injuries
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Pathologic Processes
Signs and Symptoms, Respiratory