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Clinical Trials/NCT05301543
NCT05301543
Recruiting
Not Applicable

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

University of Pennsylvania1 site in 1 country20 target enrollmentJanuary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Insomnia
Sponsor
University of Pennsylvania
Enrollment
20
Locations
1
Primary Endpoint
Sleep Pill Dosage
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
May 20, 2028
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nalaka Gooneratne

Associate Professor

University of Pennsylvania

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Sleep Efficiency(28-day follow-up)

Study Sites (1)

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