Obstructive Sleep ApneaNCT04013399
Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea and Pregnancy Related, run by Barnes-Jewish Hospital at 1 site in United States.
Trial summary
This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Pregnancy Related, Insulin Sensitivity
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Mar 2023
- Phase
- Interventional
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 28-32 weeks pregnant
- Age 20-39
- BMI 30-40 kg/m2 pre-pregnancy (or first trimester)
- Obstructive Sleep Apnea (AHI≥15)
- Have a singleton pregnancy
Who cannot join
- Diabetes (GDM, type 1 or type 2)
- Using beta blockers or glucocorticoids
- Have children who are ≤2 yrs old (risk of disrupted sleep)
- Diagnosed sleep disorders (other than sleep apnea)
- Night work schedule
- Diagnosed congestive heart failure
- Diagnosed lung disease (e.g. asthma, chronic obstructive pulmonary disease)
- Pre-gestational hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63127
About this study
This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.
Read the detailed description
Obstructive Sleep Apnea (OSA) worsens over pregnancy and is related to increased risk of gestational diabetes. Despite the fact that sleep disturbances are common during pregnancy, OSA remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. At least 25 percent of pregnancies are now affected by obesity, a leading risk factor for OSA, yet the effect of treatment of OSA on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. Inflammation with OSA may decrease insulin sensitivity. Continuous positive airway pressure (CPAP) is a known effective treatment for OSA and has been shown to improve insulin sensitivity outside of pregnancy. Our overall hypothesis is that, compared with standard care, CPAP will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. Using a randomized controlled trial, we will determine the effect of CPAP on metabolic dysfunction induced by OSA in pregnant women with obesity.
- Being tested
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Women will receive Continuous Positive Airway Pressure (CPAP) for one month. Receives: Device: Continuous Positive Airway Pressure |
| Control | No intervention | Women will receive standard prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test
Change in whole body insulin sensitivity measured using Matsuda Index
Measured: 1 month
Percent of Oxygen in blood by pulse oximetry
Change in oxygen saturation measured by pulse oximetry
Measured: 1 month
Secondary outcomes (2)
Percent of Oxygen in Adipose Tissue measured by oxygen tension probe
Change in adipose tissue oxygenation measured by oxygen tension
Measured: 1 month
Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing
Change in adipose tissue gene expression of inflammatory markers
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jul 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Why it stopped: Delayed due to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Sarah Farabi, Barnes-Jewish Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013399
- Sponsor's protocol ID
- 201905166
- Status last verified
- Jul 2023
- First submitted
- 23 May 2019
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
- ClinicalTrials.gov ID
- NCT04013399
- Acronym / sponsor ID
- 201905166
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delayed due to Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barnes-Jewish HospitalUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 9 Jul 2019 (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.
This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.
Detailed description
Obstructive Sleep Apnea (OSA) worsens over pregnancy and is related to increased risk of gestational diabetes. Despite the fact that sleep disturbances are common during pregnancy, OSA remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. At least 25 percent of pregnancies are now affected by obesity, a leading risk factor for OSA, yet the effect of treatment of OSA on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. Inflammation with OSA may decrease insulin sensitivity. Continuous positive airway pressure (CPAP) is a known effective treatment for OSA and has been shown to improve insulin sensitivity outside of pregnancy. Our overall hypothesis is that, compared with standard care, CPAP will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. Using a randomized controlled trial, we will determine the effect of CPAP on metabolic dysfunction induced by OSA in pregnant women with obesity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Device: Continuous Positive Airway PressureWomen will receive Continuous Positive Airway Pressure (CPAP) for one month. |
| Control | No intervention | –Women will receive standard prenatal care. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 28-32 weeks pregnant
- Age 20-39
- BMI 30-40 kg/m2 pre-pregnancy (or first trimester)
- Obstructive Sleep Apnea (AHI≥15)
- Have a singleton pregnancy
Key exclusion criteria (8 listed)
- Diabetes (GDM, type 1 or type 2)
- Using beta blockers or glucocorticoids
- Have children who are ≤2 yrs old (risk of disrupted sleep)
- Diagnosed sleep disorders (other than sleep apnea)
- Night work schedule
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 |
|---|---|---|
| Continuous Positive Airway PressureThe device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance. | Device | Continuous Positive Airway Pressure |
Primary outcome
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test
Time frame: 1 month
Change in whole body insulin sensitivity measured using Matsuda Index
Percent of Oxygen in blood by pulse oximetry
Time frame: 1 month
Change in oxygen saturation measured by pulse oximetry
2 secondary outcomes
Percent of Oxygen in Adipose Tissue measured by oxygen tension probe
Time frame: 1 month
Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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?
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea and Pregnancy Related, run by Barnes-Jewish Hospital 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test (time frame: 1 month). 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?
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 27 Jul 2023.