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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
Must not have
Previously prescribed, current or planned therapy for sleep apnea.
Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of delivery
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently or will be treated for sleep apnea.
Select...
I need oxygen for a chronic lung condition and might not respond to CPAP therapy.
Select...
I am currently taking prescribed medication for insomnia.
Select...
I do not have liver disease, low platelets, active bleeding, genetic issues, drug/alcohol use, or unstable mental health.
Select...
My kidney function is impaired with a creatinine level over 1.3 mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post birth
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnosis of Hypertensive Disorders of Pregnancy
Secondary study objectives
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%
Epidermal and dermal conditions
14%
Aural disorders NEC
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Respiratory disorders NEC
7%
Gallbladder disorders
7%
Female reproductive tract infections and inflammations
7%
Upper respiratory tract disorders (excl infections)
7%
Tendon, ligament and cartilage disorders
7%
Headaches
4%
Mood disorders and disturbances NEC
4%
Diverticular disorders
4%
Muscle disorders
4%
Gastrointestinal infections
4%
Suicidal and self-injurious behaviors NEC
4%
Glucose metabolism disorders
4%
Demyelinating disorders
4%
Gastrointestinal motility
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Urinary tract signs and symptoms
4%
Depressed mood disorders and disturbances
4%
Genitourinary tract disorders NEC
4%
Procedural related injuries and complicatins NEC
4%
Ocular infections, irritations and inflammations
4%
Bone and joint injuries
4%
Anxiety disorders and symptoms
4%
Skin and subcutaneous tissue infections and infestations
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1740
Find a Location
Who is running the clinical trial?
The George Washington University Biostatistics CenterLead Sponsor
26 Previous Clinical Trials
109,832 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,067 Previous Clinical Trials
2,745,944 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,796,443 Total Patients Enrolled
Andrew Bremer, MD, PhD, MASStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4 Previous Clinical Trials
42,175 Total Patients Enrolled
Rebecca Clifton, PhDPrincipal InvestigatorThe George Washington University Biostatistics Center
6 Previous Clinical Trials
21,266 Total Patients Enrolled
Francesca Facco, MDStudy ChairMagee Women's Hospital of UPMC
2 Previous Clinical Trials
370 Total Patients Enrolled
Monica Longo, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
8 Previous Clinical Trials
46,579 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.