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Assisted Therapy for Pregnancy-Related Insomnia

N/A
Waitlist Available
Led By Nalaka Gooneratne, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a relaxation technique to help pregnant women with insomnia.

Who is the study for?
This trial is for pregnant women aged 18-55 in their second or third trimester, who have trouble falling asleep or staying asleep at least three nights a week for over a month. They must be fluent in English and have access to a smartphone or tablet. Women with night shift work schedules or other medical issues that could interfere with the study can't participate.
What is being tested?
The study is testing how well behavioral relaxation techniques help improve sleep in pregnant women with insomnia. It involves learning sleep hygiene practices and participating in assisted therapy using technology like smartphones or tablets.
What are the potential side effects?
Since this trial focuses on non-medical interventions like behavioral relaxation and assisted therapy, there are no direct side effects as you might expect from medication; however, participants may experience varying levels of effectiveness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PSQI, Sleep Quality
Total Wake Time, Sleep Diary

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ART and Sleep HygieneExperimental Treatment2 Interventions
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
Group II: Sleep HygieneActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Hygiene
2018
Completed Phase 2
~1120

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,076 Previous Clinical Trials
42,719,805 Total Patients Enrolled
Nalaka Gooneratne, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

Assisted Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05530863 — N/A
Sleep Disorders Research Study Groups: ART and Sleep Hygiene, Sleep Hygiene
Sleep Disorders Clinical Trial 2023: Assisted Therapy Highlights & Side Effects. Trial Name: NCT05530863 — N/A
Assisted Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05530863 — N/A
~5 spots leftby Sep 2025
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