Evaluation of SLEEP Program

Sleep Clinical Trial

Official title:

Sleep Education for Elders Program Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727619
• Other study ID #: STUDY00003748
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Michigan State University
• Contact: Robin Tucker, PhD
• Phone: 5173533408
• Email: TUCKER98[@]MSU.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• participants who choose to enroll in the SLEEP program

Exclusion Criteria:

• younger than 40 years of age

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• SLEEP program
SLEEP is a 6-week educational program designed to improve sleep hygiene and habits.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality: Pittsburgh Sleep Quality Index	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
Primary	Sleep quality: Pittsburgh Sleep Quality Index	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
Primary	Sleep duration	Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index	immediately after the program
Primary	Sleep duration	Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index	Six months after program completion
Primary	Daytime sleepiness	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
Primary	Daytime sleepiness	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
Primary	Insomnia symptoms	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
Primary	Insomnia symptoms	As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.	Six months after program completion
Primary	Sleep hygiene habits	As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.	immediately after the program
Primary	Sleep hygiene habits	As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.	Six months after program completion
Secondary	Sleep-related knowledge	As measured by several questions related to sleep health and hygiene	immediately after the program
Secondary	Sleep-related knowledge	As measured by several questions related to sleep health and hygiene	six months later
Secondary	Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration	As measured by questions measuring personal satisfaction with sleep quality and duration	immediately after the program
Secondary	Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration	As measured by questions measuring personal satisfaction with sleep quality and duration	six months later
Secondary	Program satisfaction: questions and comments related to program experiences	As measured by questions and comments related to program experiences	immediately after the program
Secondary	Program satisfaction: questions and comments related to program experiences	As measured by questions and comments related to program experiences	six months later