Status:

COMPLETED

Treatment for Insomnia During Pregnancy

Lead Sponsor:

Stanford University

Collaborating Sponsors:

National Institute of Nursing Research (NINR)

Conditions:

Sleep Initiation and Maintenance Disorders

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.

Eligibility Criteria

Inclusion

  • Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
  • Pregnant with gestational age between 18-32 weeks.
  • Adequately fluent in English or Spanish.

Exclusion

  • Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
  • Co-morbid psychiatric disorder
  • Use of medications, herbs or other drugs with known effects on sleep
  • Unstable medical conditions
  • Currently engaged in psychotherapy or other treatments for insomnia

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2018

Estimated Enrollment :

194 Patients enrolled

Trial Details

Trial ID

NCT01846585

Start Date

April 1 2013

End Date

March 1 2018

Last Update

July 23 2018

Active Locations (1)

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1

Stanford University

Palo Alto, California, United States, 94305