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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103443 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One, Video | Experimental | One-time sleep hygiene education |
|
| Group Two, Video Plus Texts | Experimental | One-time sleep hygiene education plus repeated education through automated text messaging |
|
| Group Three, | No Intervention | Control group with no intervention assigned |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-time educational video | Behavioral | Sleep hygiene educational tips provided through a video participants watch on their own. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change on the Perceived Stress Scale | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. | 6-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley M Pfeiffer, DPT | Black Hills State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Black Hills State University | Spearfish | South Dakota | 57799 | United States |
all IPD that underlie results in a publication
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We recruited 125 participants who completed the informed consent and intial evaluation. Six participants dropped out due to personal reasons leaving 119 participants that were able to see the study through to the conclusion. Funding ran out prior to being able to recruit any additional participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group One, Video | One-time sleep hygiene education |
| FG001 | Group Two, Video Plus Texts | One-time sleep hygiene education plus repeated education through automated text messaging |
| FG002 | Group Three, | Control group with no intervention assigned |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group One, Video | One-time sleep hygiene education |
| BG001 | Group Two, Video Plus Texts | One-time sleep hygiene education plus repeated education through automated text messaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | One person did not complete the PSQI on follow-up in the video only group due to technology error. | Posted | Mean | Standard Deviation | Score on a scale | 6-weeks |
|
From enrollment until end of follow-up, 6 week time period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group One, Video | One-time sleep hygiene education | 0 |
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Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley Pfeiffer | Black Hills State University | 6053815370 | ashley.pfeiffer@bhsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2024 | Oct 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2024 | Oct 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Three arm study: No intervention, video only, video plus text messaging
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| Educational video plus repeated education | 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. |
|
| BG002 | Group Three, | Control group with no intervention assigned |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Readiness to change sleep behavior 0-10 visual analog scale | Each participant was asked, "How ready are you to change your sleep behaviors?" They were given a scale from 0, which read "not at all ready to change sleep behaviors" and then had options of 1,2,3,4,5,6,7,8,9, and 10. 10 read "completely ready to change sleep behaviors." Each participant chose which number most reflected where they were at on their readiness to change their sleep behaviors at that current moment in time. 0 indicated they weren't feeling ready, and 10 indicated feeling completely ready. | The average score on the readiness to change 0-10 scale is documented below for each intervention group. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Group Three, | Control group with no intervention assigned |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6-weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 week period |
|
|
|
| Primary | Change Score Total Sleep Time | The average total sleep time per night in minutes for each participant was recorded. | Posted | Mean | Standard Deviation | minutes per night | 6 weeks |
|
|
|
| Primary | Change Score for Total Time Awake | The average total time awake per night in minutes for each participant was recorded. | Posted | Mean | Standard Deviation | minutes per night | 6 weeks |
|
|
|
| Secondary | Change on the Perceived Stress Scale | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. | Posted | Mean | Standard Deviation | score on a scale | 6-weeks |
|
|
|
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Group Two, Video Plus Texts | One-time sleep hygiene education plus repeated education through automated text messaging | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | Group Three, | Control group with no intervention assigned | 0 | 39 | 0 | 39 | 0 | 39 |
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