Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults

February 14, 2024 updated by: Ashley Pfeiffer, Black Hills State University
This will be a study looking at trying to change community-dwelling older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • South Dakota
      • Spearfish, South Dakota, United States, 57799
        • Black Hills 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Any adult between the ages of 50 and 80 will be recruited for the study

Exclusion Criteria:

  • Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One-time educational video
A one-time educational video on best practices for good sleep hygiene
Behavioral: One-time educational video
One-time educational video
Experimental: One-time educational video plus automated text messaging
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
Behavioral: One-time educational video plus automated text messaging
Educational video plus automated text messaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index
Time Frame: Baseline and 4-week follow up
Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality
Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index
Time Frame: Baseline and 4-week follow up
Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.
Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale
Time Frame: Baseline and 4-week follow up
Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.
Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale
Time Frame: Baseline and 4-week follow up
Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.
Baseline and 4-week follow up
Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.
Time Frame: Baseline, 4-week follow up
Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score.
Baseline, 4-week follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale
Time Frame: Baseline and 4-week follow up
Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.
Baseline and 4-week follow up
Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale
Time Frame: Baseline and 4-week follow up
Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10.
Baseline and 4-week follow up
Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index
Time Frame: baseline and 4-week follow up
Body mass index is measured by body weight [kg]/ height [m]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight.
baseline and 4-week follow up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Black Hills State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashley M Pfeiffer, Black Hills 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BlackHillsST
  • P20GM103443 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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