Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)

NCT02086448 | Completed Results DMC

• 3 other identifiers: PRO13080159R01HL120354K12HD043441
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand how sleep apnea, a common sleep disorder in which a person has one or more pauses in breathing or shallow breaths while sleeping, may affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant women with sleep apnea.

Conditions

Obese; Pregnancy; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (6)

• Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound

  The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of \<30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity.

  early pregnancy (14-16 weeks gestation)

• Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement

  sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia.

  early pregnancy (14-16 weeks gestation)

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin

  Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5)

  early pregnancy (14-16 weeks gestation)

• Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound

  The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of \<30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity.

  late pregnancy (28-32 weeks gestation)

• Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement

  sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia.

  late pregnancy (28-32 weeks gestation)

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin

  Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5)

  late pregnancy (28-32 weeks gestation)

Secondary Outcomes (1)

• Placental Histology and Immunohistochemistry

  After delivery (expected 37-40 weeks gestation)

Other Outcomes (5)

• Mean Arterial Blood Pressure (mmHg) Angiogenic Domain

  early pregnancy (14-16 weeks gestation)

• Pregnancy Outcome Data

  At time of delivery (expected 37-40 weeks gestation)

• Mean Arterial Blood Pressure (mmHg) Angiogenic Domain

  late pregnancy (28-32 weeks gestation)

Study Arms (4)

Obese, SDB negative

NO INTERVENTION

No intervention, observational comparison group

Obese, SDB postive, CPAP

ACTIVE COMPARATOR

Therapeutic CPAP

Device: CPAP

Obese, SDB postive, sham-CPAP

SHAM COMPARATOR

Sham (non-therapeutic) CPAP

Device: sham-CPAP

Obese, SDB postive, sleep hygiene

OTHER

Sleep hygiene information and local sleep resources

Other: Sleep hygiene

Interventions

CPAP DEVICE

CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).

Also known as: Continuous Positive Airway Pressure

Obese, SDB postive, CPAP

sham-CPAP DEVICE

Obese, SDB postive, sham-CPAP

Sleep hygiene OTHER

Information about sleep apnea and healthy sleep. Information about local sleep resources

Obese, SDB postive, sleep hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women between 14 0/7 and 20 6/7 weeks gestation at the time of their initial PSG assessment.
• Pregnancy and current BMI \>=30
• Self-reported frequent snoring (\>=3x/week over past month) or self-reported non-snorer.

You may not qualify if:

• diagnosis of pregestational diabetes.
• self-report a history of sleep apena and who are using or were receommended by a physican to use a PAP device already
• twins

Sponsors & Collaborators

• Francesca Facco, MD: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Magee-Womens Hospital of the UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Facco FL, Wolsk J, Patel SR, Hubel C, Gallaher M, Cashmere JD, Wisniewski S. A trial of positive airway pressure for the treatment of sleep apnea in pregnancy. Am J Obstet Gynecol MFM. 2023 Mar;5(3):100840. doi: 10.1016/j.ajogmf.2022.100840. Epub 2022 Dec 21.

  PMID: 36563879 DERIVED

• Onslow ML, Wolsk J, Wisniewski S, Patel S, Gallaher M, Hubel C, Cashmere DJ, Facco FL. The association between sleep-disordered breathing and maternal endothelial and metabolic markers in pregnancies complicated by obesity. J Clin Sleep Med. 2023 Jan 1;19(1):97-109. doi: 10.5664/jcsm.10254.

  PMID: 36004747 DERIVED

MeSH Terms

Conditions

Obesity; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Francesca Facco
• Organization: University of Pittsburgh

Faccof@upmc.edu

412-641-1220

Study Officials

• Francesca Facco, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 13, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 22, 2023
• Results First Posted: March 8, 2022

Record last verified: 2023-02

Locations

US (1)