Insomnia Behavioral Intervention Study

NCT05301543 | Recruiting

• 1 other identifier: 849022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sleep Efficiency

  28-day follow-up

Study Arms (2)

Behavioral approach 1

EXPERIMENTAL

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

Behavioral approach 2

ACTIVE COMPARATOR

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

Interventions

Experimental: Behavioral approach 1 BEHAVIORAL

Includes changing sleep habits and cognitions around sleep from a mental level

Behavioral approach 1

Comparator: Behavioral approach 2 BEHAVIORAL

Includes changing sleep habits and awarenes of sleep from a perception level

Behavioral approach 2

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Alex J Mathew

CONTACT

215-596-9715; alex.mathew@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 29, 2022
• Study Start: January 10, 2022
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): May 20, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)