Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
NCT ID: NCT05530863
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
20 participants
INTERVENTIONAL
2022-04-01
2027-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sleep Hygiene
This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding
Sleep Hygiene
Standard Sleep Hygiene instructions.
ART and Sleep Hygiene
This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding
Sleep Hygiene
Standard Sleep Hygiene instructions.
Assisted Therapy
The participant will receive coaching calls and support
Interventions
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Sleep Hygiene
Standard Sleep Hygiene instructions.
Assisted Therapy
The participant will receive coaching calls and support
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
55 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Nalaka Gooneratne
Principal Investigator
Principal Investigators
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Nalaka Gooneratne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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848419
Identifier Type: -
Identifier Source: org_study_id
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