Insomnia Behavioral Intervention Study

Chronic Insomnia Clinical Trial

— IBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301543
• Other study ID #: 849022
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: May 20, 2025

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Alex J Mathew
• Phone: 215-596-9715
• Email: alex.mathew[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 20, 2025
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Experimental: Behavioral approach 1
Includes changing sleep habits and cognitions around sleep from a mental level
• Comparator: Behavioral approach 2
Includes changing sleep habits and awarenes of sleep from a perception level

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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