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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PSQI, Sleep Quality

Total Wake Time, Sleep Diary

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

2019

Completed Phase 2

~1030

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,068 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this experiment still accepting participants?

"According to the information uploaded on clinicaltrials.gov, this particular medical trial is no longer recruiting patients; its last update was made on September 2nd of 2022. Nevertheless, there are 340 alternative studies that are actively searching for volunteers at present."

Answered by AI

Is the age requirement for enlistment in this experiment exceeding 25 years?

"This trial demands that participants fit a specific age range, between 18 and 55 years old. If a patient falls outside this window, there are 43 studies for minors or 248 trials available to those over 65."

Answered by AI

Could I be a participant in this experimental research?

"This research opportunity is open to individuals between the ages of 18 and 55 who are suffering from insomnia. There is space for about 20 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Nalaka Gooneratne 2022. "Behavioral Relaxation Approaches for Insomnia in Pregnant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05530863.

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