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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-11-1-0826 | Other Grant/Funding Number | Department of Defense |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal sleep breathing | No Intervention | Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention. | |
| BiPAP -Auto for sleep apnea | Experimental | 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. |
|
| BiPAP (AVAPS) for nocturnal hypoventilation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Short Term Effects on Daily Symptoms and Medical Events | 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 | Months 0-16 after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Sitrin, Md | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26297810 | Derived | 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. |
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93 subjects were enrolled in the study. 2 subjects were found to be ineligible due to level of spinal cord injury. 91 patients remained in the study and were asked to keep daily logs of symptoms. 17 subjects were unable or unwilling to come to the first study visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Sleep Breathing | Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Origination to Beginning Therapy |
|
| |||||||||||||||||||||
| Therapy Portion of Study (12 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Sleep Breathing | Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention. |
| BG001 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Month 4 after enrollment |
|
12 months from the allocation to the device (or not) to the end of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Sleep Breathing | Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert G. Sitrin, M.D. | University of Michigan Health System | (734) 936-5201 | rsitrin@umich.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006935 | Hypercapnia |
| D013119 | Spinal Cord Injuries |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
| BiPAP/AVAPS (Phillips Respironics) | Device | 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. |
|
| Short Term Effects of Noninvasive Ventilatory Support on Quality of Life | 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. | Months 4-16 |
| Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism | 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 | Months 4-16 |
| Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing | 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. | Month 4 after enrollment |
| NOT COMPLETED |
|
|
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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). | Posted | Number | participants | Overnight testing (4-13 hours) |
|
|
|
| Other Pre-specified | Short Term Effects on Daily Symptoms and Medical Events | 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 | Not Posted | Months 0-16 after enrollment | Participants |
| Other Pre-specified | Short Term Effects of Noninvasive Ventilatory Support on Quality of Life | 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. | Not Posted | Months 4-16 | Participants |
| Other Pre-specified | Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism | 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 | Not Posted | Months 4-16 | Participants |
| Other Pre-specified | Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing | 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. | Not Posted | Month 4 after enrollment | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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. 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. | 0 | 40 | 0 | 40 |
| EG002 | 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. 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. | 0 | 23 | 0 | 23 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012138 |
| Respiratory Therapy |