The Sleep in Pregnancy Study

NCT ID: NCT03248219

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2018-03-20

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.

Conditions

Pregnancy Related; Sleep Disordered Breathing; Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado Clinical & Translational Sciences Institute

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah S Farabi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-2568

Identifier Type: -

Identifier Source: org_study_id