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Positive Airway Pressure Device
CPAP for Sleep Apnea in Pregnancy (SLEEP Trial)
N/A
Recruiting
Led By Rebecca Clifton, PhD
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of delivery
Awards & highlights
SLEEP Trial Summary
This trial will test whether treatment for sleep apnea can reduce the rate of pregnancy-related hypertension disorders.
Who is the study for?
This trial is for pregnant women between 14 and nearly 22 weeks along, with a single baby, diagnosed with mild to moderate obstructive sleep apnea. Women must not have severe kidney disease, be on long-term steroids for asthma, use sleeping pills or oxygen therapy, or have certain other health conditions.Check my eligibility
What is being tested?
The study tests if using CPAP (a machine that helps keep airways open) during pregnancy can lower the risk of high blood pressure disorders like preeclampsia compared to just getting sleep advice.See study design
What are the potential side effects?
CPAP may cause discomfort such as nasal congestion, dry mouth, skin irritation from the mask, headaches or ear pressure. However, many find it improves overall sleep quality.
SLEEP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild to moderate sleep apnea.
SLEEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnosis of Hypertensive Disorders of Pregnancy
Secondary outcome measures
Birth trauma
Birth weight
Cesarean Delivery
+13 moreSide effects data
From 2014 Phase 2 trial • 53 Patients • NCT0118777132%
Respiratory tract infections
21%
Drowsy driving
18%
Injuries NEC
14%
Aural disorders NEC
14%
Epidermal and dermal conditions
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Upper respiratory tract disorders (excl infections)
7%
Headaches
7%
Gallbladder disorders
7%
Tendon, ligament and cartilage disorders
7%
Female reproductive tract infections and inflammations
7%
Respiratory disorders NEC
4%
Anxiety disorders and symptoms
4%
Suicidal and self-injurious behaviors NEC
4%
Gastrointestinal infections
4%
Gastrointestinal motility
4%
Procedural related injuries and complicatins NEC
4%
Glucose metabolism disorders
4%
Genitourinary tract disorders NEC
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Ocular infections, irritations and inflammations
4%
Diverticular disorders
4%
Bone and joint injuries
4%
Muscle disorders
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
4%
Urinary tract signs and symptoms
4%
Demyelinating disorders
4%
Depressed mood disorders and disturbances
4%
Mood disorders and disturbances NEC
4%
Skin and subcutaneous tissue infections and infestations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure
SLEEP Trial Design
2Treatment groups
Experimental Treatment
Group I: Sleep Advice ControlExperimental Treatment1 Intervention
Initial sleep advice counseling alone
Group II: Continuous Positive Airway PressureExperimental Treatment1 Intervention
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
The George Washington University Biostatistics CenterLead Sponsor
23 Previous Clinical Trials
101,460 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,671,297 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,850,094 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently or will be treated for sleep apnea.I need oxygen for a chronic lung condition and might not respond to CPAP therapy.I have needed steroids for my asthma for more than 2 weeks in the last 6 months.I am currently taking prescribed medication for insomnia.I have been diagnosed with mild to moderate sleep apnea.You must be between 14 weeks and 21 weeks pregnant based on a clinical evaluation and ultrasound.I do not have liver disease, low platelets, active bleeding, genetic issues, drug/alcohol use, or unstable mental health.You have antiphospholipid antibody syndrome, which could affect the main diagnosis of the study.My kidney function is impaired with a creatinine level over 1.3 mg/dL.You cannot sleep in a place where you can use the CPAP machine at least 5 nights per week.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Positive Airway Pressure
- Group 2: Sleep Advice Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant intake for this clinical trial?
"Yes, the information on clinicaltrials.gov asserts that this examination is currently recruiting participants. This experiment was posted to the website on July 20th 2018 and has seen its most recent update take place on June 14th 2022. 1500 people need to be accepted from 11 trial locations for it to be completed successfully."
Answered by AI
Are there any slots accessible for participants in this research?
"According to clinicaltrials.gov, this investigation is still in search of participants; it was initially made available on July 20th 2018 and modified most recently on June 14th 2022."
Answered by AI
What is the current number of healthcare facilities that are in charge of this trial?
"11 medical institutions are currently enrolling patients, such as Magee Women's Hospital of UPMC in Pittsburgh, Ohio State University Hospital in Columbus and the University of Texas Medical Branch in Galveston."
Answered by AI
Who else is applying?
What state do they live in?
California
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Northwestern University
Columbia University
University of Alabama - Birmingham
Other
Why did patients apply to this trial?
I want to have another baby in the future and I want to do what I can to reduce risk to having preeclampsia and another traumatic birth and postpartum. My second baby was in the nicu for 4 months. I would do anything to bring a baby home right away after giving birth.
PatientReceived 2+ prior treatments
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