Obstructive Sleep ApneaNCT01882257
Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
A study testing BiPAP and BiPAP/AVAPS (Phillips Respironics) in people with Obstructive Sleep Apnea and Hypercapnia, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury
- What is being tested?
- BiPAP and BiPAP/AVAPS (Phillips Respironics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- C1-T6 spinal cord injury for at least 3 months
- living within 100 miles of Ann Arbor, Michigan, USA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
- 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).
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury
- Being tested
- BiPAP, BiPAP/AVAPS (Phillips Respironics)
- Keywords
- obstructive sleep apnea, sleep-disordered breathing, hypercapnia, spinal cord injury
- Medical subject headings
- Sleep Apnea, Obstructive, Hypercapnia, Spinal Cord Injuries, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAPDevice
Also called BiPAP-auto (Phillips Respironics)
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BiPAP |
| 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. Receives: Device: BiPAP/AVAPS (Phillips Respironics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Overnight testing (4-13 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert G. Sitrin, M.D., University of Michigan
- Investigators
- Robert G Sitrin, Md, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882257
- Sponsor's protocol ID
- HUM00051504
- Other IDs
- W81XWH-11-1-0826
- Status last verified
- Jan 2017
- First submitted
- 17 Jun 2013
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26297810
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01882257
- Acronym / sponsor ID
- HUM00051504
- Conditions
- Obstructive Sleep Apnea, Hypercapnia, Spinal Cord Injury
- Keywords
- obstructive sleep apnea, sleep-disordered breathing, hypercapnia, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: BiPAPPatients 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 | Device: BiPAP/AVAPS (Phillips Respironics)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- C1-T6 spinal cord injury for at least 3 months
- living within 100 miles of Ann Arbor, Michigan, USA
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiPAPAlso: BiPAP-auto (Phillips Respironics)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. | Device | BiPAP -Auto for sleep apnea |
| 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. | Device | BiPAP (AVAPS) for nocturnal hypoventilation |
Primary outcome
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.
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26297810Bauman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Sitrin, Md principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP and BiPAP/AVAPS (Phillips Respironics) in people with Obstructive Sleep Apnea and Hypercapnia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults (time frame: Month 4 after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.