Sleep Hygiene
Conditions
Keywords
Behavior Change, Older adults, sleep hygiene
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.
Detailed description
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.
Interventions
BEHAVIORALOne-time educational video
Sleep hygiene educational tips provided through a video participants watch on their own.
BEHAVIORALEducational 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.
Sponsors
National Institute of General Medical Sciences (NIGMS)
Black Hills State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Three arm study: No intervention, video only, video plus text messaging
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Score of Pittsburgh Sleep Quality Index | 6-weeks | 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 |
| Change Score of Sleep Hygiene Index | 6-weeks | 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. |
| Change Score of Epworth Sleepiness Scale | 6 week period | 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. |
| Change Score Total Sleep Time | 6 weeks | The average total sleep time per night in minutes for each participant was recorded. |
| Change Score for Total Time Awake | 6 weeks | The average total time awake per night in minutes for each participant was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on the Perceived Stress Scale | 6-weeks | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group One, Video One-time sleep hygiene education | 39 |
| Group Two, Video Plus Texts One-time sleep hygiene education plus repeated education through automated text messaging | 41 |
| Group Three, Control group with no intervention assigned | 39 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Group One, Video | Group Three, | Group Two, Video Plus Texts |
|---|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 7.2 | 66.5 years STANDARD_DEVIATION 8.2 | 66.3 years STANDARD_DEVIATION 7.4 | 66.7 years STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 39 Participants | 39 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 115 Participants | 36 Participants | 39 Participants | 40 Participants |
| Readiness to change sleep behavior 0-10 visual analog scale | 6.49 units on a scale STANDARD_DEVIATION 3.07 | 5.97 units on a scale STANDARD_DEVIATION 3.3 | 6.43 units on a scale STANDARD_DEVIATION 2.89 | 7.02 units on a scale STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 78 Participants | 23 Participants | 24 Participants | 31 Participants |
| Sex: Female, Male Male | 41 Participants | 16 Participants | 15 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 41 | 0 / 39 |
Outcome results
Primary
Change Score for Total Time Awake
The average total time awake per night in minutes for each participant was recorded.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change Score for Total Time Awake | -2.9 minutes per night | Standard Deviation 22.8 |
| Group Two, Video Plus Texts | Change Score for Total Time Awake | -1.7 minutes per night | Standard Deviation 12.7 |
| Group Three, | Change Score for Total Time Awake | 2.3 minutes per night | Standard Deviation 13.2 |
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.
Time frame: 6 week period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change Score of Epworth Sleepiness Scale | 1.6 score on a scale | Standard Deviation 3.3 |
| Group Two, Video Plus Texts | Change Score of Epworth Sleepiness Scale | 1.71 score on a scale | Standard Deviation 2.1 |
| Group Three, | Change Score of Epworth Sleepiness Scale | 0.39 score on a scale | Standard Deviation 3.5 |
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
Time frame: 6-weeks
Population: One person did not complete the PSQI on follow-up in the video only group due to technology error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change Score of Pittsburgh Sleep Quality Index | 1 Score on a scale | Standard Deviation 3.01 |
| Group Two, Video Plus Texts | Change Score of Pittsburgh Sleep Quality Index | 1.12 Score on a scale | Standard Deviation 2.87 |
| Group Three, | Change Score of Pittsburgh Sleep Quality Index | -0.615 Score on a scale | Standard Deviation 3.02 |
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change Score of Sleep Hygiene Index | 2.41 score on a scale | Standard Deviation 5.79 |
| Group Two, Video Plus Texts | Change Score of Sleep Hygiene Index | 1.97 score on a scale | Standard Deviation 5.29 |
| Group Three, | Change Score of Sleep Hygiene Index | .64 score on a scale | Standard Deviation 3.78 |
Primary
Change Score Total Sleep Time
The average total sleep time per night in minutes for each participant was recorded.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change Score Total Sleep Time | -2.9 minutes per night | Standard Deviation 52.9 |
| Group Two, Video Plus Texts | Change Score Total Sleep Time | 8.24 minutes per night | Standard Deviation 56.9 |
| Group Three, | Change Score Total Sleep Time | -4.3 minutes per night | Standard Deviation 45.4 |
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group One, Video | Change on the Perceived Stress Scale | -0.11 score on a scale | Standard Deviation 3.85 |
| Group Two, Video Plus Texts | Change on the Perceived Stress Scale | 1.71 score on a scale | Standard Deviation 4.51 |
| Group Three, | Change on the Perceived Stress Scale | 0.23 score on a scale | Standard Deviation 3.17 |