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出境医 / 临床实验 / Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

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.

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Percent of Oxygen in Adipose Tissue measured by oxygen tension probe [ Time Frame: 1 month ]
    Change in adipose tissue oxygenation measured by oxygen tension
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
Official Title  ICMJE Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Pregnancy Related
  • Insulin Sensitivity
Intervention  ICMJE Device: Continuous Positive Airway Pressure
The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.
Study Arms  ICMJE
  • Experimental: Continuous Positive Airway Pressure
    Women will receive Continuous Positive Airway Pressure (CPAP) for one month.
    Intervention: Device: Continuous Positive Airway Pressure
  • No Intervention: Control
    Women will receive standard prenatal care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013399
Other Study ID Numbers  ICMJE 201905166
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sarah Farabi, Barnes-Jewish Hospital
Study Sponsor  ICMJE Barnes-Jewish Hospital
Collaborators  ICMJE Washington University School of Medicine
Investigators  ICMJE Not Provided
PRS Account Barnes-Jewish Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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