Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

NCT04013399 | Withdrawn DMC

• 1 other identifier: 201905166
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Pregnancy Related; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percent of Oxygen in Adipose Tissue measured by oxygen tension probe

  1 month

• Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing

  1 month

Study Arms (2)

Continuous Positive Airway Pressure

EXPERIMENTAL

Women will receive Continuous Positive Airway Pressure (CPAP) for one month.

Device: Continuous Positive Airway Pressure

Control

NO INTERVENTION

Women will receive standard prenatal care.

Interventions

Continuous Positive Airway Pressure DEVICE

The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• weeks pregnant
• Age 20-39
• BMI 30-40 kg/m2 pre-pregnancy (or first trimester)
• Obstructive Sleep Apnea (AHI≥15)
• Have a singleton pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Barnes-Jewish Hospital: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63127, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Insulin Resistance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: July 9, 2019
• Study Start: July 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: March 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)