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Targeted CPAP Therapy for OSA in Pregnancy

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ClinicalTrials.gov Identifier: NCT02755831
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Dennis Spence, United States Naval Medical Center, San Diego

Brief Summary:
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP group (n = 180) or to a Standard Prenatal Care group (n = 180). Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the AHI ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again at 12 weeks postpartum.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP Other: Pre-natal care Not Applicable

Detailed Description:

Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for OSA (defined as an apnea hypopnea index [AHI] ≥5 events/hour; risk factors:

prepregnancy BMI≥30 kg/m2, chronic hypertension, pregestational diabetes (type 1 or type 2), history of prior preeclampsia, and/or a twin gestation) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late

= between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Sleep Study + CPAP group (n = 180)
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
Device: CPAP
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea

Standard Prenatal Care group (n=180)
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Other: Pre-natal care
Standard Pre-Natal Care




Primary Outcome Measures :
  1. Primary Objective [ Time Frame: 3 years ]
    Rate of adverse maternal outcomes.


Secondary Outcome Measures :
  1. Secondary Objective [ Time Frame: 3 years ]
    Rate of adverse fetal outcomes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
  2. Between 6 and 16 weeks gestation at time of enrollment.

Exclusion Criteria

  1. Current diagnosis and treatment of OSA.
  2. Patient refusal to randomization.
  3. Permanent Pacemaker (interfere with WATCHPAT sleep study).
  4. Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
  5. Coronary artery disease or congestive heart failure or cardiomyopathy.
  6. Not delivering and completing their postpartum visit at NMCSD.
  7. Inability to read or understand the consent.
  8. <18 years of age.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755831


Contacts
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Contact: Theodore C Morrison, PhD 619-453-9936 theodore.c.morrison.ctr@mail.mil
Contact: Dennis L Spence, PhD 619-218-9676 dennis.l.spence.mil@mail.mil

Locations
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United States, California
Naval Medical Center Recruiting
San Diego, California, United States, 92134
Contact: Theodore Morrison, PhD, MPH    619-532-8447    theodore.c.morrison.ctr@mail.mil   
Principal Investigator: Lutgendorf Monica, MD         
Sub-Investigator: Morrison Theodore, PhD         
Sub-Investigator: Nardulli Patrick, MS         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Study Director: Dennis L Spence, PhD United States Naval Medical Center, San Diego

Publications of Results:

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Responsible Party: Dennis Spence, Anesthesia Nurse, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02755831     History of Changes
Other Study ID Numbers: NMCSD.2016.0029
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to submit manuscripts to appropriate journals and present data at appropriate conferences

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases