Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Hospital, Orthopedic, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2017 |
| Start Date: | October 2011 |
| End Date: | February 2016 |
- 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).
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).
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.
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.
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
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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