The Sleep in Pregnancy Study

Completed

• Conditions: Pregnancy Related; Obesity; Sleep Disordered Breathing

• Registration Number: NCT03248219
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are common during pregnancy, SDB remains under-recognized, under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity. Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB, patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area with major therapeutic implications to improve maternal and infant health. Using a prospective design in which diet and gestational age are highly controlled, the investigators propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep monitoring system. In parallel, robust patterns of glycemia will be measured with a continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to measure insulin action. The investigators global hypothesis is that worse SDB in part accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT) pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g oral glucose tolerance test (Matsuda Model). Early identification and treatment has the potential to decrease long-term maternal cardiovascular morbidity and mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Primary Completion: 2018-03-15
• Study Completion: 2018-03-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Pregnant women:

  1. Between the ages of 20-39 yrs,
  2. At 32-34 weeks gestation,
  3. Who have a BMI of ≥30 to ≤40 kg/m2,
  4. Who have a singleton pregnancy, and
  5. Who have a normal glucose tolerance test on entrance to the study.

Exclusion Criteria

• Pregnant Women:

  1. Who have a diagnosis of diabetes (GDM, type 1 or type 2),
  2. Who are using beta blockers/glucocorticoids.
  3. Who have other children who are ≤2 yrs old (due to risk of disrupted sleep),
  4. With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome),
  5. Who work night or rotating shifts,
  6. Who report use of sleep medications will be excluded,
  7. With diagnosed pulmonary or cardiovascular disease
  8. Who do not speak English.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Insulin resistance of the Pregnant Mother	2 hours after a 75 gram glucose load	Insulin resistance will be measured with an Oral Glucose Tolerance Test
24 hour glycemia measurement of the Pregnant Mother	Every 24 hours for 3 days	Glycemia will be measured by Continuous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Infant Body Composition	At 2 weeks of life	Percent of Fat Mass
Stress Levels	15 minutes before Sleep and 15 minutes after sleep	Cortisol Levels

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States