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Insomnia Behavioral Intervention Study (IBI)

Primary Purpose

Chronic Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Behavioral approach 1
Comparator: Behavioral approach 2
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral approach 1

Behavioral approach 2

Arm Description

This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.

This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
February 3, 2022
Last Updated
October 16, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05301543
Brief Title
Insomnia Behavioral Intervention Study
Acronym
IBI
Official Title
Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
April 8, 2024 (Anticipated)
Study Completion Date
May 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral approach 1
Arm Type
Experimental
Arm Description
This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.
Arm Title
Behavioral approach 2
Arm Type
Active Comparator
Arm Description
This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Behavioral approach 1
Intervention Description
Includes changing sleep habits and cognitions around sleep from a mental level
Intervention Type
Behavioral
Intervention Name(s)
Comparator: Behavioral approach 2
Intervention Description
Includes changing sleep habits and awarenes of sleep from a perception level
Primary Outcome Measure Information:
Title
Sleep Pill Dosage
Description
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).
Time Frame
28-day follow-up
Secondary Outcome Measure Information:
Title
Sleep Efficiency
Description
Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28).
Time Frame
28-day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex J Mathew
Phone
215-596-9715
Email
alex.mathew@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex J Mathew
Phone
215-596-9715
Email
alex.mathew@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Nalaka Gooneratne, MD, MSc.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Insomnia Behavioral Intervention Study

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