Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02100943

Enrollment

Registered

2014-04-01

Start date

2014-03-31

Completion date

2016-11-14

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSA, Pregnancy

Keywords

Obstructive Sleep Apnea

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in incidence of Obstructive Sleep Apnea (OSA)	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.

Countries

United States

Outcome results