Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum

This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the third trimester of pregnancy and again postpartum.

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Key information

Conditions

Pregnancy Apnea Dyssomnias Nervous System Diseases OSA Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Wake Forest School of Medicine, Forsyth Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

This is a prospective cohort study to evaluate the presence or absence of OSA in the third trimester of pregnancy and again postpartum. The investigators will use the Watch-PAT200® device as their accepted standard for diagnosis of obstructive sleep apnea.

When enrolled, women will be taught how to use the Watch-PAT200® via a company produced video that will be shown in the clinic and will be available via YouTube for review later if needed. They will also complete the Berlin Questionnaire. The patient will then use the Watch-PAT200® device overnight to evaluate for obstructive sleep apnea. This will be performed between 32-36 weeks gestation. Apnea-hypopnea indices (AHI) will be calculated and an AHI>5 will be considered diagnostic for OSA.

The next morning when the patient returns the Watch-PAT200® device they will exhale into the NIOX MINO® to assess their exhaled nitric oxide levels. This will be performed between 800-1000 am by one of the study personnel.

The patient will also wear the Watch-PAT200® device the first postpartum night. The entire process will be repeated between 6-8 weeks postpartum.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female (> or equal 18 year of age)
Pregnant between 32 0/7 prior to 35 6/7 weeks gestation
Anticipated delivery at Forsyth Medical Center: Winston Salem, North Carolina

Exclusion criteria

Illicit drug/Alcohol abuse
Current treatment for obstructive sleep apnea
Age <18 years
Inability to speak/read English proficiently enough to give informed consent
Usage of alpha blockers or short acting nitrates
Permanent pacemaker
Sustained non-sinus cardiac arrhythmias

Treatment and study plan

Primary outcomes

Difference in incidence of Obstructive Sleep Apnea (OSA)

Time frame: 6-8 weeks postpartum

The difference in incidence of OSA during the third trimester and postpartum. We assumed an incidence of 25% during the third trimester, reducing to 6% postpartum. Comparison will be made with McNemar's test on proportions at an α level of 0.05.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Exhaled Nitric Oxide as a Biomarker of Gestational Obstructive Sleep Apnea and Persistence Postpartum

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Apr 1, 2014
Registry last updated: Apr 20, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed