Obstructive Sleep ApneaNCT03318003

Auto-PAP Therapy For Improved Fetal Growth

A study testing Auto-PAP in people with Obstructive Sleep Apnea and Pregnancy, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Obstructive Sleep Apnea, Pregnancy
What is being tested?: Auto-PAP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2017to 3 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Heath System
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Conditions: Obstructive Sleep Apnea, Pregnancy
Being tested: Auto-PAP
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03318003
Study group	Role	What they receive
Auto-PAP Therapy	Experimental	Not described Receives: Device: Auto-PAP
No Therapy	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 3rd trimester

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20173 Aug 2020

First posted23 Oct 2017
Study start1 Dec 2017
Primary completion3 Aug 2020
Study completion3 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03318003
Sponsor's protocol ID: HUM00132040
Other IDs: N023548
Status last verified: Nov 2022
First submitted: 13 Oct 2017
Last updated: 18 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Auto-PAP Therapy For Improved Fetal Growth
ClinicalTrials.gov ID: NCT03318003
Acronym / sponsor ID: HUM00132040
Conditions: Obstructive Sleep Apnea, Pregnancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: ResMed Foundation
Study start: 1 Dec 2017 (actual)
Primary completion: 3 Aug 2020 (actual)
Study completion: 3 Aug 2020 (actual)
First posted: 23 Oct 2017 (actual)
Results: Posted 25 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Auto-PAP Therapy	Experimental	Device: Auto-PAP
No Therapy	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Auto-PAPWomen will be using the Auto-PAP device nightly from randomization to end of pregnancy	Device	Auto-PAP Therapy

Primary outcome

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

1 secondary outcome

Presence or Absence of Placental Hypoxia
Time frame: At delivery the placenta will be collected and processed.

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Auto-PAP Therapy	21	20
No Therapy	22	20

Primary outcome: Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester

Time frame: 3rd trimester. Count of participants. Unit: Participants

Measure	Auto-PAP Therapy n = 18	No Therapy n = 21
Value	8	8

Auto-PAP Therapy vs No Therapy: Pearson Chi Square: 0.76, p = 0.92, Chi-squared

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: through delivery up to a maximum of 33 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Auto-PAP Therapy	0 of 21 (0%)	0 of 21 (0%)	0 of 21
No Therapy	2 of 22 (9.1%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Louise M O'Brien, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Auto-PAP in people with Obstructive Sleep Apnea and Pregnancy, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester (time frame: 3rd trimester). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.