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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
No Placebo-Only Group

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.
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.
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.

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.
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I use sleeping pills at least 3 nights a week.
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I have been diagnosed with Chronic Insomnia by a doctor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep Pill Dosage
Secondary study objectives
Sleep Efficiency

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: 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
2,081 Previous Clinical Trials
42,724,800 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
~2 spots leftby Apr 2025
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