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Sleep Apnea in Pregnancy Screening Study (SAPSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585844
First Posted: April 26, 2012
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Judette Louis, MetroHealth Medical Center
  Purpose

Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.

The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.


Condition
Sleep Apnea Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity

Resource links provided by NLM:


Further study details as provided by Judette Louis, MetroHealth Medical Center:

Primary Outcome Measures:
  • The prevalence of sleep apnea in obese pregnant women [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ]

Secondary Outcome Measures:
  • Alterations in biomarkers of inflammation and oxidative stress [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ]
  • The prevalence of maternal and neonatal morbidity [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ]

Biospecimen Retention:   Samples With DNA
urine serum

Enrollment: 182
Study Start Date: August 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with sleep apnea
Women without sleep apnea

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obstetric care clinic at a tertiary care hospital
Criteria

Inclusion Criteria:

  • Prepregnancy BMI of 30kg/m2 or greater
  • Singleton pregnancy
  • 18 years or older

Exclusion Criteria:

  • Chronic use of narcotics or other CNS drugs
  • Inability to sleep beyond 2 hours
  • 3 or more missed prenatal visits
  Contacts and Locations
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): NCT01585844


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Judette Louis, MD, MPH MetroHealth Medical Center
  More Information

Publications:
Responsible Party: Judette Louis, Assistant Professor, Reproductive Biology, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01585844     History of Changes
Other Study ID Numbers: RWJ64323
First Submitted: April 23, 2012
First Posted: April 26, 2012
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Judette Louis, MetroHealth Medical Center:
sleep apnea
pregnancy
obesity

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases


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