Sleep Apnea, ObstructiveOSA-CHTNNCT03230110
OSA in Pregnant Women With Chronic HTN
An observational study of Sleep Apnea, Obstructive and Pregnancy, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Pregnancy, Hypertension
- What is being tested?
- WP200U home sleep study device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2017to 30 Apr 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN.
Who may be able to join
- Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum service.
- Gestational age 10 weeks, 0 days to 20 weeks, 6 days
- 18 years or older
- English speaking
- They will be enrolled into one of two groups:-Chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group
- The two groups will be matched for body mass index to control for the effect of obesity on OSA diagnosis and HTN.
- Subjects will be not be excluded if they have an established diagnosis of OSA that is not currently being treated.
Who cannot join
- Being treated for OSA
- On chronic opioids
- On alpha-blockers (which can interfere with the PAT signal)
- Have secondary HTN
- Unwilling to remove nail polish and/or shorten one nail (which can also interfere with the PAT signal)
- Have a severe allergy to latex
- Do not speak English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Hospital
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension
The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device
- Conditions
- Sleep Apnea, Obstructive, Pregnancy, Hypertension
- Being tested
- WP200U home sleep study device
- Keywords
- Sleep disordered breathing, Obstructive sleep apnea, Hypertension, Pregnancy
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WP200U home sleep study deviceDiagnostic test
Also called WatchPAT
WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hypretension in Pregnancy | Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits) Receives: Diagnostic Test: WP200U home sleep study device | |
| Normotensive in Pregnancy | Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group. Receives: Diagnostic Test: WP200U home sleep study device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of OSA in pregnant women with chronic HTN
Measured: 20 months
Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN
Measured: 20 months
Secondary outcomes (4)
Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN
Measured: 20 months
Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.
Measured: 20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN
Measured: 20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start16 Jun 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
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 Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Obstetric Anesthesia and Perinatology
- Responsible party
- Sponsor
- Investigators
- Jennifer Dominguez, MD, MHS, Principal investigator, Duke University Medical Center, Dept Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230110
- Sponsor's protocol ID
- Pro00081272
- Acronym
- OSA-CHTN
- Status last verified
- Oct 2018
- First submitted
- 24 Jul 2017
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominguez JE, Grotegut CA, Wright MC, Habib AS. Obstructive Sleep Apnea Among Gravidas With Chronic Hypertension Compared to Matched Controls: A Prospective Cohort Study. Anesth Analg. 2023 Feb 1;136(2):205-214. doi: 10.1213/ANE.0000000000006223. Epub 2022 Nov 10.
PubMed 36355613
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension
- ClinicalTrials.gov ID
- NCT03230110
- Acronym / sponsor ID
- OSA-CHTN / Pro00081272
- Conditions
- Sleep Apnea, Obstructive, Pregnancy, Hypertension
- Keywords
- Sleep disordered breathing, Obstructive sleep apnea, Hypertension, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Society for Obstetric Anesthesia and Perinatology
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 26 Jul 2017 (actual)
- 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.
The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Hypretension in Pregnancy | – | Diagnostic Test: WP200U home sleep study devicePregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits) |
| Normotensive in Pregnancy | – | Diagnostic Test: WP200U home sleep study devicePregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN.
Key inclusion criteria (7 listed)
- Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum service.
- Gestational age 10 weeks, 0 days to 20 weeks, 6 days
- 18 years or older
- English speaking
- They will be enrolled into one of two groups:-Chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group
Key exclusion criteria (7 listed)
- Being treated for OSA
- On chronic opioids
- On alpha-blockers (which can interfere with the PAT signal)
- Have secondary HTN
- Unwilling to remove nail polish and/or shorten one nail (which can also interfere with the PAT signal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WP200U home sleep study deviceAlso: WatchPATWP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time. | Diagnostic test | Chronic Hypretension in Pregnancy, Normotensive in Pregnancy |
Primary outcome
Prevalence of OSA in pregnant women with chronic HTN
Time frame: 20 months
Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN
Time frame: 20 months
4 secondary outcomes
Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN
Time frame: 20 months
Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.
Time frame: 20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN
Time frame: 20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.
Time frame: 20 months
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 24 Sep 2019.
- Derived from this study: PubMed 36355613Dominguez JE, Grotegut CA, Wright MC, Habib AS. Obstructive Sleep Apnea Among Gravidas With Chronic Hypertension Compared to Matched Controls: A Prospective Cohort Study. Anesth Analg. 2023 Feb 1;136(2):205-214. doi: 10.1213/ANE.0000000000006223. Epub 2022 Nov 10.
- Individual participant dataSharing planned: No
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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.
Jennifer Dominguez, MD, MHS principal investigator
Duke University Medical Center, Dept Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Pregnancy, run by Duke University at 2 sites 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 7 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence of OSA in pregnant women with chronic HTN (time frame: 20 months). The study lists 2 primary outcomes in all. 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 NCT03230110, 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 24 Sep 2019.