Back to results

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Primary Purpose

Obstructive Sleep Apnea, Pregnancy Related, Insulin Sensitivity

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Continuous Positive Airway Pressure

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Positive Airway Pressure

Control

Arm Description

Women will receive Continuous Positive Airway Pressure (CPAP) for one month.

Women will receive standard prenatal care.

Outcomes

Primary Outcome Measures

Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test

Change in whole body insulin sensitivity measured using Matsuda Index

Percent of Oxygen in blood by pulse oximetry

Change in oxygen saturation measured by pulse oximetry

Secondary Outcome Measures

Percent of Oxygen in Adipose Tissue measured by oxygen tension probe

Change in adipose tissue oxygenation measured by oxygen tension

Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing

Change in adipose tissue gene expression of inflammatory markers

Full Information

NCT ID

NCT04013399

First Posted

May 23, 2019

Last Updated

July 26, 2023

Sponsor

Barnes-Jewish Hospital

Collaborators

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04013399

Brief Title

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Official Title

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Delayed due to Covid-19

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barnes-Jewish Hospital

Collaborators

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Pregnancy Related, Insulin Sensitivity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Positive Airway Pressure

Arm Type

Experimental

Arm Description

Women will receive Continuous Positive Airway Pressure (CPAP) for one month.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Women will receive standard prenatal care.

Intervention Type

Device

Intervention Name(s)

Continuous Positive Airway Pressure

Intervention Description

The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Primary Outcome Measure Information:

Title

Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test

Description

Change in whole body insulin sensitivity measured using Matsuda Index

Time Frame

1 month

Title

Percent of Oxygen in blood by pulse oximetry

Description

Change in oxygen saturation measured by pulse oximetry

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Percent of Oxygen in Adipose Tissue measured by oxygen tension probe

Description

Change in adipose tissue oxygenation measured by oxygen tension

Time Frame

1 month

Title

Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing

Description

Change in adipose tissue gene expression of inflammatory markers

Time Frame

1 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Washington University in St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63127

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

We'll reach out to this number within 24 hrs