Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04013399
• Other study ID #: 201905166
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: Barnes-Jewish Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Obstructive Sleep Apnea
• Pregnancy Related
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Barnes-Jewish Hospital	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percent of Oxygen in blood by pulse oximetry	Change in oxygen saturation measured by pulse oximetry	1 month
Secondary	Percent of Oxygen in Adipose Tissue measured by oxygen tension probe	Change in adipose tissue oxygenation measured by oxygen tension	1 month
Secondary	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