STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542488
• Other study ID #: STOPBANGPREG
• Status: Completed
• Start date: February 2, 2016
• Est. completion date: March 27, 2018

Study information

• Verified date: January 2019
• Source: City Hospitals Sunderland NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 27, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnoea
• Pregnancy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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?

Diagnostic Test:
• 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.

Other:
• Epworth Sleepiness Scale
A questionnaire that rates how tired they are doing everyday tasks

Locations

Country	Name	City	State
United Kingdom	Sunderland Royal Hospital	Sunderland	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
City Hospitals Sunderland NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive Sleep Apnoea	Oxygen desaturation index (4% from baseline) > 5 per hour	Between weeks 17-28 of pregnancy
Secondary	STOPBANG score	Snore, Tired, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender	Between weeks 17-28 of pregnancy
Secondary	Modified STOPBANG score	Snore, Epworth > 10, Observed to Stop Breathing, high blood Pressure, BMI, Age, Neck circumference, Gender	Between weeks 17-28 of pregnancy

External Links

•   Information about STOPBANG validation