PregnancyNCT02100943
Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum
An observational study of Pregnancy and OSA, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the third trimester of pregnancy and again postpartum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 14 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine, Forsyth Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Exhaled Nitric Oxide as a Biomarker of Gestational Obstructive Sleep Apnea 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.
Read the 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.
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA in Pregnancy | Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in incidence of Obstructive Sleep Apnea (OSA)
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.
Measured: 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda M Street, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100943
- Sponsor's protocol ID
- 00026736
- Status last verified
- Jun 2016
- First submitted
- 27 Mar 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29609706
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Nitric Oxide as a Biomarker of Gestational Obstructive Sleep Apnea and Persistence Postpartum
- ClinicalTrials.gov ID
- NCT02100943
- Acronym / sponsor ID
- 00026736
- Keywords
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA in Pregnancy | – | –Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 29609706Street 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.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M Street, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and OSA, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in incidence of Obstructive Sleep Apnea (OSA) (time frame: 6-8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.