Results Summary
What was the research about?
People who have a traumatic brain injury, or TBI, often have sleep apnea. Sleep apnea causes the upper airway to become blocked during sleep. It can make TBI symptoms worse and make recovery difficult. Screening helps identify who is at risk for sleep apnea. Then, doctors use tests to diagnose sleep apnea.
In this study, the research team compared ways to screen for and diagnose sleep apnea in people receiving hospital rehabilitation for moderate or severe TBI. For screening, the team compared
- The STOP-Bang survey
- The MAPI survey
- The Berlin survey
- A wristband that tracked total sleep time
To diagnose sleep apnea, the research team compared
- A standard sleep test with a trained technician monitoring the patient in a sleep lab, which doctors consider the gold standard, or most reliable, test
- A sleep test using portable equipment, which is easier to do and costs less
The research team wanted to learn if using portable equipment wasn’t worse at diagnosing sleep apnea than the standard test.
What were the results?
Screening. To identify people with TBI who were at risk for moderate to severe sleep apnea, the STOP-Bang and MAPI surveys worked about the same. STOP-Bang and MAPI worked better than the Berlin survey or wristband. To identify people with TBI who were at risk for mild sleep apnea, all three surveys worked about the same and better than the wristband.
Diagnosis. Portable equipment wasn’t as good as the standard test to diagnose sleep apnea. It was less likely to detect mild sleep apnea, and it was less accurate in diagnosing sleep apnea severity for people with moderate or severe sleep apnea.
Who was in the study?
The comparison of diagnostic tests included 214 people receiving inpatient treatment for TBI at one of six rehabilitation centers across the country. The screening study included 248 people at these centers. Of these patients, 74 percent were White, 20 percent were Black, 13 percent were Hispanic, 3 percent were Asian, and 2 percent were another race or ethnicity. The average age was 44, and 82 percent were men; 61 percent had severe TBI.
What did the research team do?
The research team gave people both tests to diagnose sleep apnea on the same night. People also wore the screening wristband. Within three days, people with TBI, family members, and doctors filled out the STOP-Bang, MAPI, and Berlin surveys. Each survey asked about slightly different risk factors for sleep apnea.
The research team compared the diagnostic tests. They also looked at how well the surveys and wristband worked to screen for sleep apnea.
A person with TBI, a caregiver, nurses, doctors, and therapists helped to plan the study.
What were the limits of the study?
The study didn’t include people with very mild or very severe TBI who were unable to undergo testing. Results may differ for these people.
Future research could continue to explore ways to diagnose mild sleep apnea in people with TBI.
How can people use the results?
Hospitals can use the results when considering ways to screen for and diagnose sleep apnea in people with TBI.
Professional Abstract
Objective
To compare the effectiveness of screening and diagnostic tools in detecting and diagnosing sleep apnea among people with traumatic brain injury (TBI) undergoing inpatient rehabilitation
Study Design
Design Element | Description |
---|---|
Design | Observational: cohort study |
Population | 248 participants for screening and 214 participants for diagnosis, older than age 16, with TBI and receiving inpatient rehabilitation |
Interventions/ Comparators |
Screening:
Diagnosis:
|
Outcomes | PSG-determined sleep apnea diagnosis as indicated by the Apnea-Hypopnea Index |
Timeframe | Up to 3 days for primary outcome |
This prospective non-inferiority cohort study compared four screening methods for detecting the risk of sleep apnea in people with TBI receiving inpatient rehabilitation. The study then compared the effectiveness of diagnostic methods, including relatively accessible portable diagnostic testing versus an overnight polysomnography (PSG) sleep study, which is conducted in a laboratory. PSG is considered the best method for diagnosing sleep apnea.
The study included 248 people with moderate to severe TBI receiving care at one of six TBI Model System inpatient rehabilitation centers across the country. Of these patients, 74% were White, 20% were Black, 13% were Hispanic, 3% were Asian, and 2% were another race or ethnicity. The average age was 44, and 82% were male. Among participants, 61% had severe TBI.
Participants used all sleep study technologies, including PSG, portable sleep study, and the wrist accelerometer actigraphy device, at the same time. The study included a statistical non-inferiority test to determine whether portable diagnostic sleep studies were not unacceptably worse than PSG studies based on a minimum specificity of 0.6 and sensitivity of 0.9 with a 0.1 error margin.
Within 72 hours of testing, participants, family members, and medical staff completed the STOP-Bang questionnaire, Multivariate Apnea Prediction Index (MAPI), and Berlin Questionnaire screening tools.
People with TBI, family members, and clinicians helped to create the research questions and design the study.
Results
Screening. For identifying moderate to severe sleep apnea, the STOP-Bang and MAPI were comparable (p=0.76) and more effective than the Berlin questionnaire or actigraphy (all p<0.02). For identifying mild sleep apnea, the STOP-Bang, MAPI, and Berlin Questionnaire were comparable and more effective than actigraphy (all p<0.003).
Diagnosis. The study found moderate to strong agreement between diagnoses by portable diagnostic testing and PSG (Weighted kappa = 0.78; 95% confidence interval: 0.72, 0.83), but portable diagnostic testing was more likely to underestimate sleep apnea severity. The portable diagnostic test met non-inferiority status for specificity (lower confidence limit [LCL]: 0.807, 0.943), but not for sensitivity (LCL: 0.665, 0.764)
Limitations
The study did not include participants with very mild or very severe TBI who could not undergo sleep study tests. Results may differ for these populations.
Conclusions and Relevance
In this study, the STOP-Bang questionnaire and MAPI survey were effective tools for identifying moderate to severe sleep apnea in people with TBI undergoing inpatient rehabilitation.
Compared with PSG, portable diagnostic testing was less likely to detect sleep apnea in people with mild disease and more likely to underestimate severity of disease for people with moderate to severe sleep apnea.
Future Research Needs
Future research could explore more accessible methods to diagnose mild sleep apnea in people with TBI.
Final Research Report
View this project's final research report.
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Journal Citations (Correction)
*Arch Phys Med Rehabil. 2020 Nov 24:S0003-9993(20)31227-2. doi: 10.1016/j.apmr.2020.11.001. Epub ahead of print. Erratum for: Arch Phys Med Rehabil. 2020 Sep;101(9):1497-1508. PMID: 33246553.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the researchers referred to their study as a clinical trial, but the study was actually a prospective observational cohort study. The reviewers acknowledged that the technical definition of clinical trial might include this study but that most researchers would not classify it as a clinical trial. The researchers therefore replaced instances of clinical trial in the report with cohort study.
- Reviewers asked how the researchers accounted for missing Glasgow Coma Scale scores for participants who were “chemically paralyzed, sedated, or intubated.” The researchers stated that they imputed scores on the Glasgow Coma Scale by replacing the missing scale scores the same way that previous researchers had done. The researchers also stated that when the Glasgow Coma Scale scores were missing for all other reasons, those participants’ data were excluded from sensitivity analyses.
- Reviewers questioned why the researchers reported their results for cohorts with Apnea-Hypopnea Index scores greater than or equal to 5, as well as greater than or equal to 15, when the lower scores typically did not warrant treatment. The researchers explained that they were following common practices in the field by reporting on both cutoff scores. In addition, they added information in the discussion section referencing evidence that even mild obstructive sleep apnea had cardiovascular consequences for individuals receiving inpatient rehabilitation for a traumatic brain injury.
Conflict of Interest Disclosures
Project Information
Patient / Caregiver Partners
No information provided by awardee
Other Stakeholder Partners
- Joel Scholten, MD, National Director, Physical Medicine and Rehabilitation Services, Veterans Health Administration
- Sidney R. Hinds II, MD, COL, MC, USA; DoD Brain Health Research Program Coordinator, Blast Injury Research Program Coordinating Office Medical Advisor to the Principal Assistant for Research and Technology, United States Army Medical Research and Material Command
- Joseph "Pepper" Coulter, Stakeholder
- Jill Coulter, Stakeholder