Insomnia Behavioral Intervention Study (IBI)

Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Experimental: Behavioral approach 1; Behavioral: Comparator: Behavioral approach 2

Detailed Description

This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex J Mathew; Phone Number: 215-596-9715; Email: alex.mathew@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania School of medicine
      • Contact: Alex J Mathew; Phone Number: 215-596-9715; Email: alex.mathew@pennmedicine.upenn.edu
      • Principal Investigator: Nalaka Gooneratne, MD, MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age of 55-85
• Use of sleeping pill medication for sleep at least 3 nights a week
• Diagnosed with Chronic Insomnia by a physician
• Speaks English above a 6th-grade level
• Has access to a smartphone and/or smart tablet and can use it
• Has regular access to internet

Exclusion Criteria:

• Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)
• Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral approach 1; This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.	Behavioral: Experimental: Behavioral approach 1; Includes changing sleep habits and cognitions around sleep from a mental level
Active Comparator: Behavioral approach 2; This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.	Behavioral: Comparator: Behavioral approach 2; Includes changing sleep habits and awarenes of sleep from a perception level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Pill Dosage	We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week).	28-day follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency	Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28).	28-day follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): May 20, 2028

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 849022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No