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The Sleep in Pregnancy Study (SiP)

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ClinicalTrials.gov Identifier: NCT03248219
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Center for Womens Health Research at University of Colorado Anschutz Medical Campus
College of Nursing at University of Colorado Anschutz Medical Campus
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
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.

Condition or disease
Pregnancy Related Sleep Disordered Breathing Obesity

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 20, 2018



Primary Outcome Measures :
  1. 24 hour glycemia measurement of the Pregnant Mother [ Time Frame: Every 24 hours for 3 days ]
    Glycemia will be measured by Continuous glucose monitoring

  2. Evaluation of Insulin resistance of the Pregnant Mother [ Time Frame: 2 hours after a 75 gram glucose load ]
    Insulin resistance will be measured with an Oral Glucose Tolerance Test


Secondary Outcome Measures :
  1. Infant Body Composition [ Time Frame: At 2 weeks of life ]
    Percent of Fat Mass

  2. Stress Levels [ Time Frame: 15 minutes before Sleep and 15 minutes after sleep ]
    Cortisol Levels



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are 32-34 weeks pregnant who live in the Denver Metro Area
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248219


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Center for Womens Health Research at University of Colorado Anschutz Medical Campus
College of Nursing at University of Colorado Anschutz Medical Campus
Colorado Clinical & Translational Sciences Institute
Investigators
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Principal Investigator: Sarah S Farabi, PhD University of Colorado - Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03248219    
Other Study ID Numbers: 16-2568
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases