Back to resultsAuto-PAP Therapy For Improved Fetal Growth
Primary Purpose
Obstructive Sleep Apnea, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auto-PAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Heath System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Auto-PAP Therapy
No Therapy
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester
Secondary Outcome Measures
Presence or Absence of Placental Hypoxia
The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia
Full Information
NCT ID
NCT03318003
First Posted
October 13, 2017
Last Updated
November 16, 2022
Sponsor
University of Michigan
Collaborators
ResMed Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03318003
Brief Title
Auto-PAP Therapy For Improved Fetal Growth
Official Title
Auto-PAP Therapy For Improved Fetal Growth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
ResMed Foundation
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auto-PAP Therapy
Arm Type
Experimental
Arm Title
No Therapy
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Auto-PAP
Intervention Description
Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
Primary Outcome Measure Information:
Title
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
Description
A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester
Time Frame
3rd trimester
Secondary Outcome Measure Information:
Title
Presence or Absence of Placental Hypoxia
Description
The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia
Time Frame
At delivery the placenta will be collected and processed.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise M O'Brien, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Heath System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Auto-PAP Therapy For Improved Fetal Growth
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