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Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Hypertension
Preeclampsia

Treatments

Device: Positive Airway Pressure

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01029691
1K23HL095739-01 (U.S. NIH Grant/Contract)
F022873

Details and patient eligibility

About

The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

Full description

Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.

Enrollment

125 patients

Sex

Female

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with preeclampsia who receive care at the University of Michigan Hospitals
  • No current use of PAP therapy.
  • Willing and able to provide informed consent.

Exclusion criteria

  • Current PAP therapy
  • Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
  • Cognitively impaired and unable to understand informed consent.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

125 participants in 3 patient groups

Positive Airway Pressure (compliant)
Experimental group
Description:
This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Treatment:
Device: Positive Airway Pressure
Standard care
No Intervention group
Positive Airway Pressure (non-compliant)
Experimental group
Description:
No one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment.
Treatment:
Device: Positive Airway Pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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