NCT04727619

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Feb 2021Nov 2026

First Submitted

Initial submission to the registry

October 20, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

October 20, 2020

Last Update Submit

January 22, 2026

Conditions

Sleep

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • Sleep duration

    Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index

    immediately after the program

  • Sleep duration

    Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index

    Six months after program completion

  • 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

  • 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

  • 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

  • Insomnia symptoms

    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

    As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.

    immediately after the program

  • 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 Outcomes (6)

  • Sleep-related knowledge

    immediately after the program

  • Sleep-related knowledge

    six months later

  • Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration

    immediately after the program

  • Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration

    six months later

  • Program satisfaction: questions and comments related to program experiences

    immediately after the program

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Participants who participated in the SLEEP program.

Behavioral: SLEEP program

Control

NO INTERVENTION

Participants who did not participate in the SLEEP program.

Interventions

SLEEP programBEHAVIORAL

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

Experimental

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants who choose to enroll in the SLEEP program

You may not qualify if:

  • younger than 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Analyses will be done by blinded assessor.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2020

First Posted

January 27, 2021

Study Start

February 1, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)