NCT06129045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

November 8, 2023

Results QC Date

September 4, 2025

Last Update Submit

November 12, 2025

Conditions

Keywords

Behavior ChangeOlder adultssleep hygiene

Outcome Measures

Primary Outcomes (5)

  • Change Score of Pittsburgh Sleep Quality Index

    Change Score From Baseline to 6-week Follow up on the Pittsburgh Sleep Quality Index. Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality

    6-weeks

  • Change Score of Sleep Hygiene Index

    Change Score From Baseline to 6-week Follow up on the Sleep Hygiene Index. Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.

    6-weeks

  • Change Score of Epworth Sleepiness Scale

    Change Score From Baseline to 6-week Follow up on the Epworth Sleepiness Scale. Outcome measure for daytime sleepiness. Score ranges 0-24 with higher score equaling worst daytime sleepiness.

    6 week period

  • Change Score Total Sleep Time

    The average total sleep time per night in minutes for each participant was recorded.

    6 weeks

  • Change Score for Total Time Awake

    The average total time awake per night in minutes for each participant was recorded.

    6 weeks

Secondary Outcomes (1)

  • Change on the Perceived Stress Scale

    6-weeks

Study Arms (3)

Group One, Video

EXPERIMENTAL

One-time sleep hygiene education

Behavioral: One-time educational video

Group Two, Video Plus Texts

EXPERIMENTAL

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

Behavioral: Educational video plus repeated education

Group Three,

NO INTERVENTION

Control group with no intervention assigned

Interventions

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

Group One, Video

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 Two, Video Plus Texts

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
  • inability to wear the device on their wrist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Hills State University

Spearfish, South Dakota, 57799, United States

Location

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Ashley Pfeiffer
Organization
Black Hills State University

Study Officials

  • Ashley M Pfeiffer, DPT

    Black Hills State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three arm study: No intervention, video only, video plus text messaging
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

October 4, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

November 24, 2025

Results First Posted

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

all IPD that underlie results in a publication

Locations