Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80

NCT ID: NCT06129045

Last Updated: 2025-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2025-08-01

Brief Summary

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This will be a study looking at trying to change 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.

Detailed Description

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Older adults ages 50-80 will be recruited and placed into one of three groups. Group One will watch a one-time educational video on sleep hygiene, Group Two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video, and Group Three will be a control group with no intervention. The participants in Groups One and Two will receive the education after two weeks of data tracking on a Fitbit device. They then will have four additional weeks of tracking. At the end of the study time of six weeks, all participants will return for follow-up testing. 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.

Conditions

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Sleep Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three arm study: No intervention, video only, video plus text messaging
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group One, Video

One-time sleep hygiene education

Group Type EXPERIMENTAL

One-time educational video

Intervention Type BEHAVIORAL

Sleep hygiene educational tips provided through a video participants watch on their own.

Group Two, Video Plus Texts

One-time sleep hygiene education plus repeated education through automated text messaging

Group Type EXPERIMENTAL

Educational video plus repeated education

Intervention Type BEHAVIORAL

Sleep hygiene educational tips are provided first through a video participants watch on their own and then tips are repeated through daily automated text messaging for an additional 4 weeks.

Group Three,

Control group with no intervention assigned

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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One-time educational video

Sleep hygiene educational tips provided through a video participants watch on their own.

Intervention Type BEHAVIORAL

Educational video plus repeated education

Sleep hygiene educational tips are provided first through a video participants watch on their own and then tips are repeated through daily automated text messaging for an additional 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* own a smartphone with the capability of receiving text messages.

Exclusion Criteria

* an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
* inability to wear the device on their wrist
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Black Hills State University

OTHER

Sponsor Role lead

Responsible Party

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Ashley Pfeiffer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashley M Pfeiffer, DPT

Role: PRINCIPAL_INVESTIGATOR

Black Hills State University

Locations

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Black Hills State University

Spearfish, South Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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P20GM103443

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BHSU

Identifier Type: -

Identifier Source: org_study_id

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