Auto-PAP Therapy For Improved Fetal Growth

November 16, 2022 updated by: Louise O'Brien, University of Michigan
The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • 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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Heath System

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • at least 18 years old;
  • no more than 20 weeks pregnant;
  • pregnant with one baby;
  • found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study.

Exclusion Criteria:

  • more than 20 weeks pregnant;
  • pregnant with twins, triplets, or more babies;
  • a current smoker, drink alcohol, or use recreational drugs;
  • currently using positive-airway pressure therapy for treatment of obstructive sleep apnea;
  • diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auto-PAP Therapy
Device: Auto-PAP
Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
No Intervention: No Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
Time Frame: 3rd trimester
A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester
3rd trimester

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or Absence of Placental Hypoxia
Time Frame: At delivery the placenta will be collected and processed.
The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia
At delivery the placenta will be collected and processed.

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

ResMed Foundation

Investigators

  • Principal Investigator: Louise M O'Brien, PhD, University of Michigan

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)

December 1, 2017

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00132040
  • N023548 (Other Grant/Funding Number: ResMed Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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