Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury
Conditions
Keywords
obstructive sleep apnea, sleep-disordered breathing, hypercapnia, spinal cord injury
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).
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.
Interventions
DEVICEBiPAP
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.
DEVICEBiPAP/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.
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults | 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. |
| The Frequency of Technical Errors Related to the Home-based Overnight Testing. | 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
| Measure | Time frame | Description |
|---|---|---|
| Short Term Effects on Daily Symptoms and Medical Events | 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 |
| Short Term Effects of Noninvasive Ventilatory Support on Quality of Life | 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. |
| Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism | 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 |
| Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Normal Sleep Breathing Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention. | 11 |
| 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. | 40 |
| 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. | 23 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Study Origination to Beginning Therapy | Withdrawal by Subject | 0 | 2 | 1 |
| Therapy Portion of Study (12 Months) | Withdrawal by Subject | 0 | 11 | 4 |
Baseline characteristics
| Characteristic | Normal Sleep Breathing | BiPAP -Auto for Sleep Apnea | BiPAP (AVAPS) for Nocturnal Hypoventilation | Total |
|---|---|---|---|---|
| Age, Customized 18 to 75 years | 11 participants | 40 participants | 23 participants | 74 participants |
| Gender Female | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
| Gender Male | 9 Participants | 35 Participants | 20 Participants | 64 Participants |
| Region of Enrollment United States | 11 participants | 40 participants | 23 participants | 74 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 40 | 0 / 23 |
| serious Total, serious adverse events | 0 / 11 | 0 / 40 | 0 / 23 |
Outcome results
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.
Time frame: Month 4 after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entire Tested Population | Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults | Normal sleep breathing | 11 participants |
| Entire Tested Population | Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults | Sleep disordered breathing without hypercapnia | 40 participants |
| Entire Tested Population | Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults | Sleep-disordered breathing with hypercapnia | 23 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).
Time frame: Overnight testing (4-13 hours)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Entire Tested Population | The Frequency of Technical Errors Related to the Home-based Overnight Testing. | HSAT (Home Sleep Apnea Test) | 6 participants |
| Entire Tested Population | The Frequency of Technical Errors Related to the Home-based Overnight Testing. | Transcutaneous pCO2/SpO2 Monitor | 9 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.
Time frame: Month 4 after enrollment
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
Time frame: Months 4-16
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.
Time frame: Months 4-16
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
Time frame: Months 0-16 after enrollment