Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

NCT02709174

Pulmonary Embolism

COMPLETED

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

NCT04013399

Obstructive Sleep Apnea Pregnancy Related Insulin Sensitivity

WITHDRAWN NA

Sleep Apnea Syndrome in Obese Women During Pregnancy

NCT03509805

Apnea, Obstructive Sleep Pregnancy Complications Pre-Eclampsia +1 more

COMPLETED NA

Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

NCT01030003

Sleep Apnea Syndromes

COMPLETED

Hemodynamic and Respiratory Function in Healthy Pregnant Women

NCT00199693

Healthy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy OSA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OSA in Pregnancy

Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No