Insomnia Behavioral Intervention Study

Not Applicable

Recruiting

• Conditions: Chronic Insomnia

• Registration Number: NCT05301543
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-04-08
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep Pill Dosage	28-day follow-up	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States