Obstructive Sleep ApnoeaNCT02542488
STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy
An observational study of Obstructive Sleep Apnoea and Pregnancy, run by City Hospitals Sunderland NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score > 10 with the tired item) calculated and then be tested with overnight… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Pregnancy
- What is being tested?
- STOPBANG Questionnaire, Overnight pulse oximetry and Epworth Sleepiness Scale
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2016to 27 Mar 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women booked to deliver at Sunderland Royal Hospital who have a body mass index ≥40 at their first midwife appointment.
Who may be able to join
- Pregnant women
- Body mass index ≥ 40 at first midwife appointment
- Women ≥ 18 years of age
Who cannot join
- Pre-existing obstructive sleep apnoea on treatment
- Pre-existing restrictive or obstructive respiratory disease
- Women with another cause of sleep apnoea (e.g. central sleep apnoea)
- Women under 18 years of age
- Women who do not provide or refuse consent
- Women lacking capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sunderland Royal Hospital
Sunderland, Tyne and Wear, SR4 7TP
About this study
Official title: Use of the STOPBANG Questionnaire for Predicting Obstructive Sleep Apnoea in Pregnancy
This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score > 10 with the tired item) calculated and then be tested with overnight pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.
Read the detailed description
Obstructive sleep apnoea (OSA) is a condition in which the muscles and soft tissues of the throat collapse during sleep, resulting in them stopping breathing for a short period. It affects around 4% of all pregnant women and is more common in obese people. Pregnant women with untreated OSA are more likely to have pregnancy complications and are more likely to need a caesarean section. Babies born to mothers with untreated OSA are more likely to need neonatal treatment. If OSA is diagnosed and treated then these risks are reduced. In non-pregnant patients presenting for surgery, an screening tool called STOPBANG has been proven to be effective in identifying patients with OSA.
S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male?
The investigators aim to assess whether STOPBANG can be used to identify OSA in obese pregnant women.
The aim is to recruit 100 pregnant women with a body mass index (BMI) ≥40 at Sunderland Royal Hospital. Data will be collected when they attend for their anomaly scan or glucose tolerance test (during the second trimester of pregnancy). Participants will complete an Epworth sleepiness scale questionnaire and the STOP questions before having their BMI, age and neck circumference documented. A STOPBANG score and Modified STOPBANG score (substitute tired question with Epworth >10) will be calculated. All participants will then take a Rad8 pulse oximeter home to record their overnight pulse rate and oxygen saturations. The oximetry results will be analysed by a respiratory physiologist and the oxygen desaturation index will be calculated. A statistician will analyse the results to determine if there is a relationship between STOPBANG score or Modified STOPBANG score and likelihood of the pregnant women having OSA. In a secondary analysis we will then see if any individual elements of STOPBANG can be used to predict OSA.
- Conditions
- Obstructive Sleep Apnoea, Pregnancy
- Being tested
- STOPBANG Questionnaire, Overnight pulse oximetry, Epworth Sleepiness Scale
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPBANG QuestionnaireOther
8 question screening tool comprised of the following questions:
S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male?
Overnight pulse oximetryDiagnostic test
All participants will be given a Masimo Rad8 pulse oximeter to take home and apply to their finger overnight to measure their heart rate and oxygen saturations while they sleep.
Epworth Sleepiness ScaleOther
A questionnaire that rates how tired they are doing everyday tasks
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with BMI >39 at booking | All women will receive routine care and in addition will complete the 8 question STOPBANG screening tool, an Epworth sleepiness scale and have overnight oximetry recorded. Receives: Other: STOPBANG Questionnaire; Diagnostic Test: Overnight pulse oximetry; Other: Epworth Sleepiness Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Sleep Apnoea
Oxygen desaturation index (4% from baseline) > 5 per hour
Measured: Between weeks 17-28 of pregnancy
Secondary outcomes (2)
STOPBANG score
Snore, Tired, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender
Measured: Between weeks 17-28 of pregnancy
Modified STOPBANG score
Snore, Epworth > 10, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender
Measured: Between weeks 17-28 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start2 Feb 2016
- Primary completion31 Aug 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- City Hospitals Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Cope, MBBS, Principal investigator, Consultant Anaesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542488
- Sponsor's protocol ID
- STOPBANGPREG
- Status last verified
- Jan 2019
- First submitted
- 3 Sep 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pearson F, Batterham AM, Cope S. The STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea in Pregnancy. J Clin Sleep Med. 2019 May 15;15(5):705-710. doi: 10.5664/jcsm.7754.
PubMed 31053210
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the STOPBANG Questionnaire for Predicting Obstructive Sleep Apnoea in Pregnancy
- ClinicalTrials.gov ID
- NCT02542488
- Acronym / sponsor ID
- STOPBANGPREG
- Conditions
- Obstructive Sleep Apnoea, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- City Hospitals Sunderland NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 7 Sep 2015 (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.
This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score > 10 with the tired item) calculated and then be tested with overnight pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.
Detailed description
Obstructive sleep apnoea (OSA) is a condition in which the muscles and soft tissues of the throat collapse during sleep, resulting in them stopping breathing for a short period. It affects around 4% of all pregnant women and is more common in obese people. Pregnant women with untreated OSA are more likely to have pregnancy complications and are more likely to need a caesarean section. Babies born to mothers with untreated OSA are more likely to need neonatal treatment. If OSA is diagnosed and treated then these risks are reduced. In non-pregnant patients presenting for surgery, an screening tool called STOPBANG has been proven to be effective in identifying patients with OSA.
S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male?
The investigators aim to assess whether STOPBANG can be used to identify OSA in obese pregnant women.
The aim is to recruit 100 pregnant women with a body mass index (BMI) ≥40 at Sunderland Royal Hospital. Data will be collected when they attend for their anomaly scan or glucose tolerance test (during the second trimester of pregnancy). Participants will complete an Epworth sleepiness scale questionnaire and the STOP questions before having their BMI, age and neck circumference documented. A STOPBANG score and Modified STOPBANG score (substitute tired question with Epworth >10) will be calculated. All participants will then take a Rad8 pulse oximeter home to record their overnight pulse rate and oxygen saturations. The oximetry results will be analysed by a respiratory physiologist and the oxygen desaturation index will be calculated. A statistician will analyse the results to determine if there is a relationship between STOPBANG score or Modified STOPBANG score and likelihood of the pregnant women having OSA. In a secondary analysis we will then see if any individual elements of STOPBANG can be used to predict OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with BMI >39 at booking | – | Other: STOPBANG Questionnaire, Diagnostic Test: Overnight pulse oximetry, Other: Epworth Sleepiness ScaleAll women will receive routine care and in addition will complete the 8 question STOPBANG screening tool, an Epworth sleepiness scale and have overnight oximetry recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women booked to deliver at Sunderland Royal Hospital who have a body mass index ≥40 at their first midwife appointment.
Key inclusion criteria (3 listed)
- Pregnant women
- Body mass index ≥ 40 at first midwife appointment
- Women ≥ 18 years of age
Key exclusion criteria (6 listed)
- Pre-existing obstructive sleep apnoea on treatment
- Pre-existing restrictive or obstructive respiratory disease
- Women with another cause of sleep apnoea (e.g. central sleep apnoea)
- Women under 18 years of age
- Women who do not provide or refuse consent
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 |
|---|---|---|
| STOPBANG Questionnaire8 question screening tool comprised of the following questions: S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male? | Other | Pregnant women with BMI >39 at booking |
| Overnight pulse oximetryAll participants will be given a Masimo Rad8 pulse oximeter to take home and apply to their finger overnight to measure their heart rate and oxygen saturations while they sleep. | Diagnostic test | Pregnant women with BMI >39 at booking |
| Epworth Sleepiness ScaleA questionnaire that rates how tired they are doing everyday tasks | Other | Pregnant women with BMI >39 at booking |
Primary outcome
Obstructive Sleep Apnoea
Time frame: Between weeks 17-28 of pregnancy
Oxygen desaturation index (4% from baseline) > 5 per hour
2 secondary outcomes
STOPBANG score
Time frame: Between weeks 17-28 of pregnancy
Modified STOPBANG score
Time frame: Between weeks 17-28 of pregnancy
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 1 Feb 2019.
- Derived from this study: PubMed 31053210Pearson F, Batterham AM, Cope S. The STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea in Pregnancy. J Clin Sleep Med. 2019 May 15;15(5):705-710. doi: 10.5664/jcsm.7754.
- Information about STOPBANG validationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sean Cope, MBBS principal investigator
Consultant Anaesthetist
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 Obstructive Sleep Apnoea and Pregnancy, run by City Hospitals Sunderland NHS Foundation Trust at 1 site in United Kingdom.
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 1 Feb 2019. 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 Kingdom. 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?
Obstructive Sleep Apnoea (time frame: Between weeks 17-28 of pregnancy). 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 NCT02542488, 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 1 Feb 2019.