The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04013399
Recruitment Status : Withdrawn (Delayed due to Covid-19)
First Posted : July 9, 2019
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Sarah Farabi, Barnes-Jewish Hospital

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Pregnancy Related Insulin Sensitivity Device: Continuous Positive Airway Pressure Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous Positive Airway Pressure
Women will receive Continuous Positive Airway Pressure (CPAP) for one month.
Device: Continuous Positive Airway Pressure
The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

No Intervention: Control
Women will receive standard prenatal care.



Primary Outcome Measures :
  1. 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

  2. Percent of Oxygen in blood by pulse oximetry [ Time Frame: 1 month ]
    Change in oxygen saturation measured by pulse oximetry


Secondary Outcome Measures :
  1. Percent of Oxygen in Adipose Tissue measured by oxygen tension probe [ Time Frame: 1 month ]
    Change in adipose tissue oxygenation measured by oxygen tension

  2. Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing [ Time Frame: 1 month ]
    Change in adipose tissue gene expression of inflammatory markers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013399


Locations
Layout table for location information
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63127
Sponsors and Collaborators
Barnes-Jewish Hospital
Washington University School of Medicine
Layout table for additonal information
Responsible Party: Sarah Farabi, Assistant Professor, Barnes-Jewish Hospital
ClinicalTrials.gov Identifier: NCT04013399    
Other Study ID Numbers: 201905166
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Insulin Resistance
Hypersensitivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases