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NCT Number: NCT05301543

Insomnia Behavioral Intervention Study

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Alex J Mathew

CONTACT

[email protected]

215-596-9715

Nalaka Gooneratne, MD, MSc.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Behavioral approach 1

Behavioral

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

Comparator: Behavioral approach 2

Behavioral

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

Primary outcomes

  1. Sleep Pill Dosage

    Time frame: 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 outcomes

  1. Sleep Efficiency

    Time frame: 28-day follow-up

    Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28).

Study contacts

Contact information is provided by the study sponsor or research team.

Alex J Mathew

CONTACT

[email protected]

215-596-9715

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: IBI

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 29, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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