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Behavioral Intervention

Behavioral Interventions for Chronic Insomnia (IBI Trial)

N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 55-85
Use of sleeping pill medication for sleep at least 3 nights a week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28-day follow-up
Awards & highlights

IBI Trial Summary

This trial will explore whether a behavior intervention can help people who have long-term insomnia and rely on sleeping pills. The study will use a smartphone app to monitor adherence.

Who is the study for?
This trial is for adults aged 55-85 who have been diagnosed with chronic insomnia and regularly use sleeping pills at least three nights a week. Participants must be able to speak English, use a smartphone or tablet, and have internet access. Those with acute medical conditions or severe mental health issues like major depression or psychosis are excluded.Check my eligibility
What is being tested?
The study compares two behavioral approaches to treat chronic insomnia in long-term users of sleeping pills. It includes sleep hygiene improvements and uses an optional smartphone app to track adherence. The goal is to reduce symptoms of insomnia and decrease reliance on medication.See study design
What are the potential side effects?
Since the interventions are non-pharmaceutical behavioral approaches, significant side effects are not expected. However, changes in sleep patterns or stress due to alterations in bedtime routines may occur.

IBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
Select...
I use sleeping pills at least 3 nights a week.
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I have been diagnosed with Chronic Insomnia by a doctor.

IBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28-day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28-day follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Pill Dosage
Secondary outcome measures
Sleep Efficiency

IBI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral approach 1Experimental Treatment1 Intervention
This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.
Group II: Behavioral approach 2Active Control1 Intervention
This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled

Media Library

Behavioral approach 1 (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05301543 — N/A
Chronic Insomnia Research Study Groups: Behavioral approach 1, Behavioral approach 2
Chronic Insomnia Clinical Trial 2023: Behavioral approach 1 Highlights & Side Effects. Trial Name: NCT05301543 — N/A
Behavioral approach 1 (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301543 — N/A
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT05301543 — N/A

Frequently Asked Questions

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

What is the upper limit for patient participation in this research endeavor?

"Affirmative. Information found on clinicaltrials.gov reveals that this medical research, which was first initiated on January 10th 2022, is presently enrolling individuals into the trial. Approximately 20 participants are needed to be sourced from one medical centre."

Answered by AI

Does the protocol for this trial take into account individuals aged seventy-five and above?

"This particular clinical trial's entry requirements specify that the minimum age for participants is 55, while 85 years old represents the upper limit."

Answered by AI

Might I be able to contribute to this research endeavor?

"This trial is recruiting 20 elderly individuals (aged between 55 and 85) who suffer from chronic insomnia, take sleeping pills 3 nights a week, have an English proficiency of at least sixth grade level, possess access to both smart devices and the internet."

Answered by AI

Are there opportunities for participants to join this research initiative?

"As indicated by clinicaltrials.gov, this research initiative is actively searching for participants - the initial posting was on January 10th 2022 and it was last modified on September 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried the following medications:. I have been on several different kinds of sleep medications that have not helped.
PatientReceived 1 prior treatment
I am currently taking Trazadone and Nortriptylene to sleep and Modafinil during the day in order to stay awake.
PatientReceived 1 prior treatment
I cannot continue on medication that doesn't work. I am as exhausted when I wake up as when I go to sleep. This is no way to live!
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many visits to Philadelphia are required?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. University of Pennsylvania School of Medicine: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Insomnia Behavioral Intervention Study
Nalaka Gooneratne 2022. "Insomnia Behavioral Intervention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301543.
All > Sleep Disorders > Insomnia
~6 spots leftby Apr 2025
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