Auto-PAP Therapy For Improved Fetal Growth

NCT03318003 | Completed Results FDA Device

• 2 other identifiers: HUM00132040N023548
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

  3rd trimester

Secondary Outcomes (1)

• Presence or Absence of Placental Hypoxia

  At delivery the placenta will be collected and processed.

Study Arms (2)

Auto-PAP Therapy

EXPERIMENTAL

Device: Auto-PAP

No Therapy

NO INTERVENTION

Interventions

Auto-PAP DEVICE

Women will be using the Auto-PAP device nightly from randomization to end of pregnancy

Auto-PAP Therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• ResMed Foundation: collaborator

Study Sites (1)

University of Michigan Heath System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Louise O'Brien
• Organization: University of Michigan

louiseo@med.umich.edu

734 647-9064

Study Officials

• Louise M O'Brien, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 23, 2017
• Study Start: December 1, 2017
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: November 18, 2022
• Results First Posted: January 25, 2022

Record last verified: 2022-11

Locations

US (1)