Status:
COMPLETED
Auto-PAP Therapy For Improved Fetal Growth
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
ResMed Foundation
Conditions:
Obstructive Sleep Apnea
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2020
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03318003
Start Date
December 1 2017
End Date
August 3 2020
Last Update
November 18 2022
Active Locations (1)
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1
University of Michigan Heath System
Ann Arbor, Michigan, United States, 48109