Recruiting

Insomnia Intervention

Sponsor:

University of Pennsylvania

Code:

NCT05301543

Conditions

Chronic Insomnia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Experimental: Behavioral approach 1

Comparator: Behavioral approach 2

Study Details

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

Study ID

NCT05301543

Start date

Jan 10, 2022

Status verified date

Jul, 2025

Completion date

May 20, 2028

Anticipated

Primary completion date

Apr 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Sleep Pill Dosage [ Time Frame: 28-day follow-up ]

Central Contacts and Locations

Central contacts

Alex J Mathew

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

Locations

University of Pennsylvania School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alex J Mathew

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

Principal Investigator:

Nalaka Gooneratne, MD, MSc.

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-07-17.