Clinical trial NCT02100943: Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum
Official title: Exhaled Nitric Oxide as a Biomarker of Gestational Obstructive Sleep Apnea and Persistence Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
OSA
Keywords: Obstructive Sleep Apnea
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in incidence of Obstructive Sleep Apnea (OSA)
timeFrame: 6-8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine, Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Linda M Street, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Street LM, Aschenbrenner CA, Houle TT, Pinyan CW, Eisenach JC. Gestational Obstructive Sleep Apnea: Biomarker Screening Models and Lack of Postpartum Resolution. J Clin Sleep Med. 2018 Apr 15;14(4):549-555. doi: 10.5664/jcsm.7042.