Sleep ApneaNCT01610648
Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea
An observational study of Sleep Apnea and Metabolic Syndrome, run by Tufts Medical Center at 1 site in United States.
Trial summary
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Metabolic Syndrome
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients presenting for a sleep study to Tufts Medical Center
Who may be able to join
- Referral to the sleep center for a diagnostic study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Center, Tufts Medical Center
Boston, Massachusetts, 02111
About this study
Official title: Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire.
The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The investigators hope to enroll 250 patients in our study at Tufts Medical Center.
Read the detailed description
We will complete a 12 item questionnaire and data sheet with the study subjects based on their responses and 2 measurements specified below, right before application of a study the start of their sleep study called "Polysomnography".
If available, we will also use information from the subjects medical record, including information regarding a history of diabetes (blood sugar that is too high), high blood pressure and laboratory data such as blood sugar and blood lipids (fats in the blood). We will record this information for research purposes.
The 2 measurements performed for research purposes consist of the size of the neck and waist using a flexible tape measure. After the sleep study, we will also use results from that study in this research. We expect the subjects study participation to be completed in 30 minutes or less.
There will be no follow up. If a participant cannot complete the sleep study for any reason, the study team may decide to withdraw the subject's participation without further notice.
The study will be open for participation from June 2012 through November of 2012.
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Keywords
- OSA, metabolic syndrome, Apnea-hypopnea index, Oxygen desaturation index
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting for a diagnostic sleep study | Patients presenting to the TMC sleep center for sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-off value determination for each of three STOP-Bang versions
Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Apnea-Hypopnea Index AHI as defined by the society for sleep medicine. The cut-off values will be calculated separately for each category of severity.
Measured: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Secondary outcomes (1)
Cut-off value determination for each of three STOP-Bang versions
Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Oxygen Desaturation Index ODI as defined by the Society for sleep medicine. The cut-off values will be calculated separately for each category of severity.
Measured: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman Schumann, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610648
- Sponsor's protocol ID
- IRB#10391
- Status last verified
- Apr 2016
- First submitted
- 23 May 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01610648
- Acronym / sponsor ID
- IRB#10391
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Keywords
- OSA, metabolic syndrome, Apnea-hypopnea index, Oxygen desaturation index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire.
The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The investigators hope to enroll 250 patients in our study at Tufts Medical Center.
Detailed description
We will complete a 12 item questionnaire and data sheet with the study subjects based on their responses and 2 measurements specified below, right before application of a study the start of their sleep study called "Polysomnography".
If available, we will also use information from the subjects medical record, including information regarding a history of diabetes (blood sugar that is too high), high blood pressure and laboratory data such as blood sugar and blood lipids (fats in the blood). We will record this information for research purposes.
The 2 measurements performed for research purposes consist of the size of the neck and waist using a flexible tape measure. After the sleep study, we will also use results from that study in this research. We expect the subjects study participation to be completed in 30 minutes or less.
There will be no follow up. If a participant cannot complete the sleep study for any reason, the study team may decide to withdraw the subject's participation without further notice.
The study will be open for participation from June 2012 through November of 2012.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting for a diagnostic sleep study | – | –Patients presenting to the TMC sleep center for sleep study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting for a sleep study to Tufts Medical Center
Key inclusion criteria (1 listed)
- Referral to the sleep center for a diagnostic study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cut-off value determination for each of three STOP-Bang versions
Time frame: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Apnea-Hypopnea Index AHI as defined by the society for sleep medicine. The cut-off values will be calculated separately for each category of severity.
1 secondary outcome
Cut-off value determination for each of three STOP-Bang versions
Time frame: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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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.
Roman Schumann, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Metabolic Syndrome, run by Tufts Medical Center 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 1 inclusion and 0 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 21 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cut-off value determination for each of three STOP-Bang versions (time frame: The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2016.