STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy

NCT ID: NCT02542488

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-02

Study Completion Date

2018-03-27

Brief Summary

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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

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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

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Obstructive Sleep Apnoea Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

STOPBANG Questionnaire

Intervention Type OTHER

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 oximetry

Intervention Type DIAGNOSTIC_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 Scale

Intervention Type OTHER

A questionnaire that rates how tired they are doing everyday tasks

Interventions

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STOPBANG Questionnaire

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?

Intervention Type OTHER

Overnight pulse oximetry

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.

Intervention Type DIAGNOSTIC_TEST

Epworth Sleepiness Scale

A questionnaire that rates how tired they are doing everyday tasks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Body mass index ≥ 40 at first midwife appointment
* Women ≥ 18 years of age

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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City Hospitals Sunderland NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Cope, MBBS

Role: PRINCIPAL_INVESTIGATOR

Consultant Anaesthetist

Locations

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Sunderland Royal Hospital

Sunderland, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31053210 (View on PubMed)

Related Links

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http://www.stopbang.ca/publication/validation.php

Information about STOPBANG validation

Other Identifiers

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STOPBANGPREG

Identifier Type: -

Identifier Source: org_study_id

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