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NCT05530863

Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Enrolling by Invitation
NAAges 18–55InterventionalTreatment
University of Pennsylvania
~20 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Assisted TherapySleep Hygiene

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PSQI, Sleep Quality
Measured over 30 days
+1 more outcome measured

Conditions

Sleep Initiation and Maintenance Disorders
Pregnancy Related

Explore related trials

Disorders of initiating and maintaining sleepPregnancy

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Nalaka Gooneratne, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age between 18 and 55
In second or third trimester of pregnancy (Gestation weeks 18-32)
Able to speak, read and write fluent English
Has regular access to a smartphone and/or smart tablet
sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for ≥3 nights/week, must persist for at least 1 month

Exclusion

Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period.
Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

What this trial measures

  • PSQI, Sleep Quality30 days

    Measured by a single item score, sleep quality is the measurement of how restful and restorative the sleep of an individual is. Pittsburgh Sleep Quality Index: Well- known questionnaire used to measure sleep quality in various patient groups. For overall sleep quality, the minimum score= 0 (better) and the maximum score=3 (worse).

  • Total Wake Time, Sleep Diary30 days

    A sleep diary will be used to gather information about the participants daily sleep pattern and schedule; gold standard of care for insomnia. This instrument will also be used to check adherence to the Gratification practice of the ART intervention. This will be administered during pre-screening and intervention.