Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP) (PAP-SAP)

November 20, 2024 updated by: Ghada Bourjeily, The Miriam Hospital

Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea

This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below).

Both groups will have:

  1. blood testing for placenta-secreted circulating markers
  2. placental histopathological and immunohistochemistry examination of placental expression of markers.

Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health.

Randomization groups include:

  1. Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls.
  2. CPAP + nasal dilator strips: Subjects randomized to positive airway pressure (PAP) therapy will receive auto-titrating PAP. Pressure requirements will be monitored remotely and pressure modified as needed. PAP adherence will be determined subjectively and objectively. This group will also receive nasal dilator strips as described above.

All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant snorers without obstructive sleep apnea, have a BMI >30 kg/m2 at recruitment
  • >18 years of age
  • <13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification)
  • Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island
  • Ability to give informed consent.

Exclusion Criteria:

  • Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims)
  • Inability to tolerate PAP therapy
  • Serious physical or mental illness or condition that would affect participation
  • Drowsy driving
  • Severe hypoxemia on sleep study
  • Advanced cardiac disease or arrhythmias that may benefit from PAP therapy
  • Chronic lung disease and / or respiratory failure.
  • Twin pregnancies
  • Fetuses with congenital anomalies
  • Severe hypertension at enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Positive Airway Pressure
Positive airway pressure and nasal dilator strips during sleep.
Device: Positive Airway Pressure
Auto-titrating PAP + nasal dilator strips during sleep
Other: Nasal Dilator Strips
Nasal dilator strips
Placebo Comparator: Nasal Dilator Strips
Nasal dilator strips during sleep.
Other: Nasal Dilator Strips
Nasal dilator strips

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alterations in circulating placenta-secreted markers.
Time Frame: up to 6 months
Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy.
up to 6 months
Changes in placental histopathology for markers of malperfusion and placental expression of markers
Time Frame: Placenta collected at time of delivery
Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers.
Placenta collected at time of delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements
Time Frame: Prior to randomization, then at approximately 3 months, and 6 months later
A 24 blood pressure monitor will be used to measure changes in daytime and nighttime average blood pressure.
Prior to randomization, then at approximately 3 months, and 6 months later
Change in a composite of adverse pregnancy outcomes
Time Frame: 8 months, delivery and 2 weeks postpartum
Pregnancy outcomes defined as gestational hypertension, gestational diabetes and preterm birth (birth prior to 37 completed weeks of pregnancy will be analyzed as a composite outcome
8 months, delivery and 2 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brown University
Brigham and Women's Hospital
Rhode Island Hospital
Women and Infants Hospital of Rhode Island

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ghada Bourjeily, MD, The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HD078515-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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