Continuous Positive Airway Pressure for Obstructive Sleep Apnea

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obstructive Sleep Apnea+2 MoreContinuous Positive Airway Pressure - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test whether treatment for sleep apnea can reduce the rate of pregnancy-related hypertension disorders.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Obstetric Complications
  • Prophylaxis of Preeclampsia

Treatment Effectiveness

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: At the time of delivery

72 hours post birth
Neonatal Seizures
Week 21
Gestational diabetes
At the time of delivery
Cesarean Delivery
By 6 weeks postpartum
Maternal adverse cardiovascular outcome composite
During delivery
Birth trauma
Shoulder dystocia
Hour 72
NICU Stay
Immediately post birth
Birth weight
Week 37
Preterm birth
Day 14
Diagnosis of Hypertensive Disorders of Pregnancy
Within 6 weeks postpartum
Maternal morbidity composite
Hour 72
Hyperbilirubinemia
Hypoglycemia
Intracranial hemorrhage
through 72 hours postpartum
Fetal or Neonatal Death
Hour 72
Neonatal encephalopathy
Neonatal respiratory support

Trial Safety

Side Effects for

Laparoscopic Gastric Banding
32%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%Respiratory disorders NEC
7%Tendon, ligament and cartilage disorders
7%Headaches
7%Gallbladder disorders
7%Female reproductive tract infections and inflammations
7%Upper respiratory tract disorders (excl infections)
4%Gastrointestinal motility
4%Gastrointestinal infections
4%Bone and joint injuries
4%Urinary tract signs and symptoms
4%Coronary artery disrders
4%Anxiety disorders and symptoms
4%Suicidal and self-injurious behaviors NEC
4%Bone disorders (excl congenital and fractures)
4%Ocular infections, irritations and inflammations
4%Diverticular disorders
4%Medication errors
4%Procedural related injuries and complicatins NEC
4%Musculoskeletal and connective tissue disorders NEC
4%Glucose metabolism disorders
4%Muscle disorders
4%Depressed mood disorders and disturbances
4%Mood disorders and disturbances NEC
4%Demyelinating disorders
4%Skin and subcutaneous tissue infections and infestations
4%Genitourinary tract disorders NEC
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01187771) in the Laparoscopic Gastric Banding ARM group. Side effects include: Respiratory tract infections with 32%, Drowsy driving with 21%, Injuries NEC with 18%, Aural disorders NEC with 14%, Epidermal and dermal conditions with 14%.

Trial Design

1 Treatment Group

Continuous Positive Airway Pressure
1 of 1

Experimental Treatment

1500 Total Participants · 1 Treatment Group

Primary Treatment: Continuous Positive Airway Pressure · No Placebo Group · N/A

Continuous Positive Airway Pressure
Device
Experimental Group · 1 Intervention: Continuous Positive Airway Pressure · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the time of delivery

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,944,499 Total Patients Enrolled
The George Washington University Biostatistics CenterLead Sponsor
22 Previous Clinical Trials
100,960 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,236,636 Total Patients Enrolled
Andrew Bremer, MD, PhD, MASStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4 Previous Clinical Trials
43,675 Total Patients Enrolled
Rebecca Clifton, PhDPrincipal InvestigatorThe George Washington University Biostatistics Center
6 Previous Clinical Trials
22,766 Total Patients Enrolled
Monica Longo, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
7 Previous Clinical Trials
47,680 Total Patients Enrolled
Francesca Facco, MDStudy ChairMagee Women's Hospital of UPMC
2 Previous Clinical Trials
370 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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