Sleep Apnea, ObstructiveOSAinPregNCT02383706
Obstructive Sleep Apnea in Pregnancy
An observational study of Sleep Apnea, Obstructive and Pregnancy, run by Duke University at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid
- What is being tested?
- ApneaLink Air, Berlin Quesionnaire and Epworth Sleepiness Scale
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women, ages 18-50 years old, BMI > or equal to 40 kg/m2, without a prior diagnosis of obstructive sleep apnea or chronic narcotic use.
Who may be able to join
- gestational age 24 to 35 weeks
- BMI > or equal to 40 kg/m2
- 18 years or older
Who cannot join
- Non-English speaking subjects
- Established diagnosis of OSA
- chronic narcotic use
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Obstructive Sleep Apnea in Pregnancy: Development of a Pregnancy-Specific Screening Tool
Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.
Read the detailed description
Following recruitment and informed consent, subjects will complete 3 screening questionnaires for OSA: the Berlin and STOP-BANG questionnaires, and the Epworth Sleepiness Scale. They will also undergo a physical exam by one of the study investigators including examination of the neck and upper airway to assess neck circumference, retrognathia, thyromental space, tongue scalloping, MMS, modified MMS, tonsil size and lateral pharyngeal wall narrowing.
Subjects will all receive ApneaLink™ Air (ResMed, Poway, CA), a FDA-approved, non-invasive, portable, home polysomnography device, and instructions for using the device during one night of sleep. They will be given contact information if they have questions regarding use of the device. Subjects will receive a prepaid FedEx envelope to return the device. They will receive a parking voucher worth up to a maximum of $7 during this appointment. Subjects will be compensated ($50 check by mail) once the device is received. A follow-up phone call will be made by the PI to inform the subject of the results of the home polysomnography study. Subjects who screen positive (AHI > 5) by home polysomnography will be referred to Duke Sleep Medicine for further evaluation. Pregnancy outcomes will be followed for all subjects.
Enrolled subjects who go on to have a cesarean delivery will be studied using ExSpiron (Respiratory Motion, Inc., Waltham, MA), a FDA-approved, non-invasive respiratory volume monitor for 24 hours. The monitor has three adhesive pads that attach to the chest wall and a cord that attaches to the monitoring device, similar to an electrocardiogram. The monitor can be detached and the study suspended when patients ambulate to the restroom, and should not interfere with breastfeeding. The monitor will be connected to the patient in the pre-operative holding area, and the monitor will be calibrated with baseline spirometry measurements using a Wright spirometer over one minute. The subject will wear the device for the duration of the surgery, in the recovery room, and for 24 following surgery. The non-invasive respiratory volume monitor will be collected by study personnel at the conclusion of the 24 hours, and no data collected from the monitor will be used for clinical decision-making. Standard of care will be followed for the antepartum, intrapartum and postpartum management of those patients. Patients will continue to be monitored using the investigators' standard protocol for patients who have received neuraxial morphine which consists of continuous monitoring for 2 hours, followed by monitoring every 2 hours for 24 hours of the following: vital signs, oxygen saturation, respiratory rate, pain score and sedation score. The investigators also have nursing standing orders for naloxone administration for respiratory rate < 8 breaths/min or Richmond Agitation Sedation Scale (RASS) ≤ -3, together with immediate notification of medical staff, as well an order to notify medical staff for oxygen saturation < 90% or RASS < -2.
- Conditions
- Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid
- Being tested
- ApneaLink Air, Berlin Quesionnaire, Epworth Sleepiness Scale, STOP-BANG questionnaire, Physical exam
- Keywords
- Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid, Complications, pregnancy
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Morbid, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLink AirDevice
Overnight, home polysomnography device
Berlin QuesionnaireBehavioural
OSA screening questionnaire
Epworth Sleepiness ScaleBehavioural
OSA screening questionnaire
STOP-BANG questionnaireBehavioural
OSA screening questionnaire
Physical examOther
Physical exam of neck, mouth and upper airway
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study. Receives: Device: ApneaLink Air; Behavioral: Berlin Quesionnaire; Behavioral: Epworth Sleepiness Scale; Behavioral: STOP-BANG questionnaire; Other: Physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.
Measured: Women studied at one time point between 24 weeks and 35 weeks gestation.
Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.
Measured: Women studied at one time point between 24 weeks and 35 weeks gestation.
Secondary outcomes (1)
Post-op Minute Ventilation Following C-section
To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring
Measured: Women studied for 24-hours following their cesarean delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383706
- Sponsor's protocol ID
- Pro00056786
- Acronym
- OSAinPreg
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2015
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dominguez JE, Grotegut CA, Cooter M, Krystal AD, Habib AS. Screening extremely obese pregnant women for obstructive sleep apnea. Am J Obstet Gynecol. 2018 Dec;219(6):613.e1-613.e10. doi: 10.1016/j.ajog.2018.09.001. Epub 2018 Sep 11.
PubMed 30217579
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Pregnancy: Development of a Pregnancy-Specific Screening Tool
- ClinicalTrials.gov ID
- NCT02383706
- Acronym / sponsor ID
- OSAinPreg / Pro00056786
- Conditions
- Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid
- Keywords
- Sleep Apnea, Obstructive, Pregnancy, Obesity, Morbid, Complications, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.
Detailed description
Following recruitment and informed consent, subjects will complete 3 screening questionnaires for OSA: the Berlin and STOP-BANG questionnaires, and the Epworth Sleepiness Scale. They will also undergo a physical exam by one of the study investigators including examination of the neck and upper airway to assess neck circumference, retrognathia, thyromental space, tongue scalloping, MMS, modified MMS, tonsil size and lateral pharyngeal wall narrowing.
Subjects will all receive ApneaLink™ Air (ResMed, Poway, CA), a FDA-approved, non-invasive, portable, home polysomnography device, and instructions for using the device during one night of sleep. They will be given contact information if they have questions regarding use of the device. Subjects will receive a prepaid FedEx envelope to return the device. They will receive a parking voucher worth up to a maximum of $7 during this appointment. Subjects will be compensated ($50 check by mail) once the device is received. A follow-up phone call will be made by the PI to inform the subject of the results of the home polysomnography study. Subjects who screen positive (AHI > 5) by home polysomnography will be referred to Duke Sleep Medicine for further evaluation. Pregnancy outcomes will be followed for all subjects.
Enrolled subjects who go on to have a cesarean delivery will be studied using ExSpiron (Respiratory Motion, Inc., Waltham, MA), a FDA-approved, non-invasive respiratory volume monitor for 24 hours. The monitor has three adhesive pads that attach to the chest wall and a cord that attaches to the monitoring device, similar to an electrocardiogram. The monitor can be detached and the study suspended when patients ambulate to the restroom, and should not interfere with breastfeeding. The monitor will be connected to the patient in the pre-operative holding area, and the monitor will be calibrated with baseline spirometry measurements using a Wright spirometer over one minute. The subject will wear the device for the duration of the surgery, in the recovery room, and for 24 following surgery. The non-invasive respiratory volume monitor will be collected by study personnel at the conclusion of the 24 hours, and no data collected from the monitor will be used for clinical decision-making. Standard of care will be followed for the antepartum, intrapartum and postpartum management of those patients. Patients will continue to be monitored using the investigators' standard protocol for patients who have received neuraxial morphine which consists of continuous monitoring for 2 hours, followed by monitoring every 2 hours for 24 hours of the following: vital signs, oxygen saturation, respiratory rate, pain score and sedation score. The investigators also have nursing standing orders for naloxone administration for respiratory rate < 8 breaths/min or Richmond Agitation Sedation Scale (RASS) ≤ -3, together with immediate notification of medical staff, as well an order to notify medical staff for oxygen saturation < 90% or RASS < -2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Device: ApneaLink Air, Behavioral: Berlin Quesionnaire, Behavioral: Epworth Sleepiness Scale, Behavioral: STOP-BANG questionnaire, Other: Physical examPregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women, ages 18-50 years old, BMI > or equal to 40 kg/m2, without a prior diagnosis of obstructive sleep apnea or chronic narcotic use.
Key inclusion criteria (3 listed)
- gestational age 24 to 35 weeks
- BMI > or equal to 40 kg/m2
- 18 years or older
Key exclusion criteria (3 listed)
- Non-English speaking subjects
- Established diagnosis of OSA
- chronic narcotic use
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 |
|---|---|---|
| ApneaLink AirOvernight, home polysomnography device | Device | Subjects |
| Berlin QuesionnaireOSA screening questionnaire | Behavioural | Subjects |
| Epworth Sleepiness ScaleOSA screening questionnaire | Behavioural | Subjects |
| STOP-BANG questionnaireOSA screening questionnaire | Behavioural | Subjects |
| Physical examPhysical exam of neck, mouth and upper airway | Other | Subjects |
Primary outcome
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Time frame: Women studied at one time point between 24 weeks and 35 weeks gestation.
Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.
Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result
Time frame: Women studied at one time point between 24 weeks and 35 weeks gestation.
Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.
1 secondary outcome
Post-op Minute Ventilation Following C-section
Time frame: Women studied for 24-hours following their cesarean delivery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30217579Dominguez JE, Grotegut CA, Cooter M, Krystal AD, Habib AS. Screening extremely obese pregnant women for obstructive sleep apnea. Am J Obstet Gynecol. 2018 Dec;219(6):613.e1-613.e10. doi: 10.1016/j.ajog.2018.09.001. Epub 2018 Sep 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea, Obstructive and Pregnancy, run by Duke University 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 3 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 19 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result (time frame: Women studied at one time point between 24 weeks and 35 weeks gestation.). 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 NCT02383706, 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 19 Jun 2019.