Auto-PAP Therapy For Improved Fetal Growth

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03318003
• Collaborator: ResMed Foundation (Other)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Pregnancy	Device: Auto-PAP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Auto-PAP Therapy For Improved Fetal Growth
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Aug 3, 2020
• Actual Study Completion Date: Aug 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Slowing of Fetal Growth by >=33% During the Last Trimester [3rd trimester]

   A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester

Secondary Outcome Measures

1. Presence of Absence of Placental Hypoxia [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Heath System	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• ResMed Foundation

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 10, 2020

More Information

Publications

None provided.

• Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03318003
• Other Study ID Numbers: HUM00132040; N023548
• First Posted: Oct 23, 2017
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• 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
• Additional relevant MeSH terms: Sleep Apnea, Obstructive

Study Results

Participant Flow

Arm/Group Title	Auto-PAP Therapy	No Therapy
Arm/Group Description	Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy	No treatment
Period Title: Overall Study
STARTED	21	22
COMPLETED	20	20
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Auto-PAP Therapy	No Therapy	Total
Arm/Group Description	Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy	No treatment	Total of all reporting groups
Overall Participants	21	22	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (4.4)	34.4 (4.2)	32.2 (4.9)
Sex: Female, Male (Count of Participants)
Female	21 100%	22 100%	43 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.8%	2 9.1%	3 7%
Not Hispanic or Latino	20 95.2%	20 90.9%	40 93%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 33.3%	1 4.5%	8 18.6%
White	14 66.7%	20 90.9%	34 79.1%
More than one race	0 0%	1 4.5%	1 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%	22 100%	43 100%
gestational age at enrollment (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	17.1 (4.4)	17.2 (4.1)	17.1 (4.2)

Outcome Measures

1. Primary Outcome

Title	Slowing of Fetal Growth by >=33% 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

Outcome Measure Data

Analysis Population Description

Because the latter part of the study was overlapping March 2020, some women did not get all of their research ultrasounds. Data below is shared for all women for whom at least one 3rd trimester ultrasound is available.

Arm/Group Title	Auto-PAP Therapy	No Therapy
Arm/Group Description	Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy	No treatment
Measure Participants	18	21
Count of Participants [Participants]	8 38.1%	8 36.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Auto-PAP Therapy, No Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments	no adjustments made
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Pearson Chi Square
	Estimated Value	0.76
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Presence of 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.

Outcome Measure Data

Analysis Population Description

Some placentas were not collected and sent to pathology as intended, perhaps in part because of fewer staff available during the COVID inflected months.

Arm/Group Title	Auto-PAP Therapy	No Therapy
Arm/Group Description	Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy	No treatment
Measure Participants	13	15
Hypoxia determinations	1 4.8%	4 18.2%
Non-hypoxia determinations	12 57.1%	11 50%

Adverse Events

Time Frame	through delivery up to a maximum of 33 weeks
Arm/Group Title	Auto-PAP Therapy		No Therapy
Arm/Group Description	Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy		No treatment
All Cause Mortality
	Auto-PAP Therapy		No Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Serious Adverse Events
	Auto-PAP Therapy		No Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		2/22 (9.1%)
Pregnancy, puerperium and perinatal conditions
Demise	0/21 (0%)	0	2/22 (9.1%)	2
Other (Not Including Serious) Adverse Events
	Auto-PAP Therapy		No Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.