NCT02542488

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

September 3, 2015

Last Update Submit

January 31, 2019

Conditions

Obstructive Sleep ApnoeaPregnancy

Outcome Measures

Primary Outcomes (1)

  • Obstructive Sleep Apnoea

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

    Between weeks 17-28 of pregnancy

Secondary Outcomes (2)

  • STOPBANG score

    Between weeks 17-28 of pregnancy

  • Modified STOPBANG score

    Between weeks 17-28 of pregnancy

Study Arms (1)

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.

Other: STOPBANG QuestionnaireDiagnostic Test: Overnight pulse oximetryOther: Epworth Sleepiness Scale

Interventions

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?

Pregnant women with BMI >39 at booking
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.

Pregnant women with BMI >39 at booking
Epworth Sleepiness ScaleOTHER

A questionnaire that rates how tired they are doing everyday tasks

Pregnant women with BMI >39 at booking

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women booked to deliver at Sunderland Royal Hospital who have a body mass index ≥40 at their first midwife appointment.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunderland Royal Hospital

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

Location

Related Publications (1)

  • 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.

    PMID: 31053210DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sean Cope, MBBS

    Consultant Anaesthetist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

February 2, 2016

Primary Completion

August 31, 2017

Study Completion

March 27, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)