Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Pregnancy Related; Insulin Sensitivity
• Intervention / Treatment: Device: Continuous Positive Airway Pressure

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63127
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test	Change in whole body insulin sensitivity measured using Matsuda Index	1 month
Percent of Oxygen in blood by pulse oximetry	Change in oxygen saturation measured by pulse oximetry	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Oxygen in Adipose Tissue measured by oxygen tension probe	Change in adipose tissue oxygenation measured by oxygen tension	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	1 month

Collaborators and Investigators

• Sponsor: Barnes-Jewish Hospital
• Collaborators: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): September 30, 2022
• Study Completion (Estimated): March 30, 2023

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Hyperinsulinism; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypersensitivity; Apnea; Insulin Resistance
• Other Study ID Numbers: 201905166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No