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Completed

NCT Number: NCT02542488

STOPBANG As A Screening Tool for 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sunderland Royal Hospital

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STOPBANG Questionnaire

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

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

Other

A questionnaire that rates how tired they are doing everyday tasks

Primary outcomes

  1. Obstructive Sleep Apnoea

    Time frame: Between weeks 17-28 of pregnancy

    Oxygen desaturation index (4% from baseline) > 5 per hour

Secondary outcomes

  1. STOPBANG score

    Time frame: Between weeks 17-28 of pregnancy

    Snore, Tired, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender

  2. Modified STOPBANG score

    Time frame: Between weeks 17-28 of pregnancy

    Snore, Epworth > 10, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender

Sponsors and collaborators

Lead sponsor

City Hospitals Sunderland NHS Foundation Trust

Other

Registry information

Official study title

Use of the STOPBANG Questionnaire for Predicting Obstructive Sleep Apnoea in Pregnancy

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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