Evaluation of SLEEP Program

January 22, 2026 updated by: Robin Tucker, Michigan State University

Sleep Education for Elders Program Evaluation

This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • participants who choose to enroll in the SLEEP program

Exclusion Criteria:

  • younger than 40 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Participants who participated in the SLEEP program.
Behavioral: SLEEP program
SLEEP is a 6-week educational program designed to improve sleep hygiene and habits.
No Intervention: Control
Participants who did not participate in the SLEEP program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality: Pittsburgh Sleep Quality Index
Time Frame: immediately after the program
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
immediately after the program
Sleep quality: Pittsburgh Sleep Quality Index
Time Frame: Six months after program completion
Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.
Six months after program completion
Sleep duration
Time Frame: immediately after the program
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
immediately after the program
Sleep duration
Time Frame: Six months after program completion
Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index
Six months after program completion
Daytime sleepiness
Time Frame: immediately after the program
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
immediately after the program
Daytime sleepiness
Time Frame: Six months after program completion
Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.
Six months after program completion
Insomnia symptoms
Time Frame: immediately after the program and six months later
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
immediately after the program and six months later
Insomnia symptoms
Time Frame: Six months after program completion
As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.
Six months after program completion
Sleep hygiene habits
Time Frame: immediately after the program
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
immediately after the program
Sleep hygiene habits
Time Frame: Six months after program completion
As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.
Six months after program completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep-related knowledge
Time Frame: immediately after the program
As measured by several questions related to sleep health and hygiene
immediately after the program
Sleep-related knowledge
Time Frame: six months later
As measured by several questions related to sleep health and hygiene
six months later
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
Time Frame: immediately after the program
As measured by questions measuring personal satisfaction with sleep quality and duration
immediately after the program
Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
Time Frame: six months later
As measured by questions measuring personal satisfaction with sleep quality and duration
six months later
Program satisfaction: questions and comments related to program experiences
Time Frame: immediately after the program
As measured by questions and comments related to program experiences
immediately after the program
Program satisfaction: questions and comments related to program experiences
Time Frame: six months later
As measured by questions and comments related to program experiences
six months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00003748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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