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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 below
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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:
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I am currently or will be treated for sleep apnea.
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I need oxygen for a chronic lung condition and might not respond to CPAP therapy.
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I am currently taking prescribed medication for insomnia.
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I do not have liver disease, low platelets, active bleeding, genetic issues, drug/alcohol use, or unstable mental health.
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My kidney function is impaired with a creatinine level over 1.3 mg/dL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post birth for reporting.

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 more

Side effects data

From 2014 Phase 2 trial • 53 Patients • NCT01187771
32%
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%
Diverticular disorders
4%
Muscle disorders
4%
Gastrointestinal infections
4%
Gastrointestinal motility
4%
Suicidal and self-injurious behaviors NEC
4%
Mood disorders and disturbances NEC
4%
Musculoskeletal and connective tissue disorders NEC
4%
Glucose metabolism disorders
4%
Demyelinating disorders
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Urinary tract signs and symptoms
4%
Anxiety disorders 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%
Skin and subcutaneous tissue infections and infestations
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
2,055 Previous Clinical Trials
2,730,394 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,790,831 Total Patients Enrolled

Media Library

Continuous Positive Airway Pressure (Positive Airway Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT03487185 — N/A
Prophylaxis of Preeclampsia Research Study Groups: Continuous Positive Airway Pressure, Sleep Advice Control
Prophylaxis of Preeclampsia Clinical Trial 2023: Continuous Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT03487185 — N/A
Continuous Positive Airway Pressure (Positive Airway Pressure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03487185 — N/A
~375 spots leftby Dec 2026
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