Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

• ClinicalTrials.gov Identifier: NCT04013399
• Recruitment Status: Withdrawn
• First Posted: July 9, 2019
• Last Update Posted: July 27, 2023
• Sponsor: Barnes-Jewish Hospital
• Collaborator: Washington University School of Medicine
• Information provided by (Responsible Party): Sarah Farabi, Barnes-Jewish Hospital

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

• 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

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

• 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

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

More Information

• Responsible Party: Sarah Farabi, Assistant Professor, Barnes-Jewish Hospital
• ClinicalTrials.gov Identifier: NCT04013399
• Other Study ID Numbers: 201905166
• First Posted: July 9, 2019
• Last Update Posted: July 27, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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