Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults
Phase: NA
Conditions: Sleep Habit, Good, Sleep Hygiene, Health Behavior
Sponsor: Black Hills State University

 
 
 
 
 
Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults  
NCT NUMBER: 05483920 
01/01/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol and Statistical Analysis Plan  
We propose investigation into the efficacy of sleep hygiene interventions on Americans ages 50-
80. This will be done by examining the effectiveness of two separate interventions on improving 
sleep hygiene habits and 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. The 
proposed research project will evaluate the efficacy of sleep hygiene education on CDOA and 
assess the ability of daily automated text messaging in CDOA to serve as an effective 
augmentation for sleep hygiene education This research topic corresponds to the South Dakota 
Biomedical Research Infrastructure Network (BRIN) area of focus: “Physiological (including 
cellular) and developmental responses to stimuli.” 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. 
Research Plan  
Specific Aim 1: Evaluate the efficacy and feasibility of sleep hygiene education on CDOA. 
Rationale: Our first aim is to determine if sleep hygiene education can be beneficial in improving 
sleep health in the CDOA population. Sleep hygiene education has been shown to be effective 
in university students, high school students, athletes, and working adults, but up until very 
recently has yet to be shown in CDOA. Recently, Tucker et al. published a pilot study looking at 
virtual sleep health education in older adults and found significant changes in sleep quality, 
maladaptive sleep health behaviors, and daytime sleepiness compared to controls. In this six-
week study, six 30-minute videos were used to educate participants on sleep health.[23] A 
variety of other sleep hygiene education tools have been used to assist in improving sleep 
health in younger populations, but a one-time educational video was chosen for this project as 
this was the most popular intervention in previous studies and because we wanted to explore if 
a one-time educational video would show similar findings as the recent 6-week Tucker et al. 
study had in regard to sleep health behavior change.[5, 23] Therefore, a 4-week, home-based, 
technology-supported program targeting sleep hygiene will be conducted among 80 CDOA, 
ages 50-80 using a 30-minute educational video. Eighty participants is based off of the 
systematic review performed by Murawski et al. which reviewed sleep health intervention 
research studies which had participant sizes ranging from 19 to 391 with a median of 84.[5] 
Taking into account a potential dropout rate of 20%, the initial total number of participants to be 
recruited will be 100. Similar studies performed in younger populations have shown 4-weeks is 
an effective time frame to implement sleep hygiene education. This in combination from data 
from the Murawski review which showed an average study duration of 5-weeks with a mode of 
4-weeks, therefore 4-weeks was chosen for our study duration.[5] During the 4-week study, 
several physiological markers will be taken. These markers will be taken from data collected on 
the FitBit Inspire HR device and will include sleep efficiency, time in bed, time actually sleeping, 
sleep midpoint, and time spent at each stage of sleep. FitBit was the device chosen to track 
these markers due to its efficacy and comparability to the Actigraph device along with FitBit’s 
usability.[32] Of the several wearable devices that track sleep on the market, FitBit is used in 
more biomedical clinical research than any other consumer wearable.[33] The FitBit Inspire HR 
2 was specifically chosen given its ability to track sleep along with it aligning most closely with 

the FitBit Alta (now out of stock with FitBit) that was proven comparable and slightly more 
accurate to actigraphy as researched by Chinoy et al. in 2020.[30] 
Experimental design: The proposed 3-year pilot study will begin in the fall (September 2022) 
and conclude before the end of the academic year (May 2025). This proposal design outlines 
the first year of this 3-year study. The first step in the experimental process will be the creation 
of a 30-minute sleep hygiene education video that will be provided to participants to watch on 
either a smartphone or computer. The video will be created by the PI and student researcher(s) 
and reviewed and modified based on feedback from the mentors. This video will include tips to 
improve sleep hygiene and habits.  The video will provide education on the value of having a 
consistent time of going to sleep and waking up in the morning, setting the bedroom up so that it 
is a comfortable temperature, dark, quiet, and relaxing.  The video will also include information 
regarding the value of removing electronic devices from the bedroom, the importance of 
exercise, along with avoiding caffeine, alcohol and large amounts of food prior to going to 
bed.[34] The principal investigator and student researcher(s) will recruit participants through 
flyers and word of mouth. Flyers will be placed at senior centers, community centers, and 
medical centers in Rapid City, SD. Interested participants will email or call Dr. Ashley Pfeiffer to 
enroll in the study. Dr. Ashley Pfeiffer will meet with the participant to determine eligibility status 
for the study. Due to the use of human subjects in this study, the research protocol will be 
approved by the University of South Dakota, Black Hills State University institutional review 
boards, and the National Institutes of Health prior to participant recruitment. Participant inclusion 
criteria will include participants ages 50-80, own a smartphone with the capability of receiving 
text messages. Exclusion criteria: a diagnosed sleep disorder such as insomnia or obstructive 
sleep apnea, and inability to wear any sleep tracking device on their wrist. During the initial visit, 
participants will read through and sign informed consent explaining the procedures and 
expectations of them during the study. The participants will then complete the following 
questionnaires related to the primary objectives of the study: the Ru-SATED questionnaire 
which includes the Sleep diary (based on the Consensus Sleep Diary) and Epworth Sleepiness 
Scale, Pittsburgh Sleep Quality Index, and the Sleep Hygiene Index. Participants will also 
complete the Perceived Stress Scale, Numeric Pain Rating Scale, and Patient Specific 
Functional Scale as secondary outcomes. Initial data collection will consist of taking 
anthropometric measurements and vital signs (Figure 1), with the assistance of the student 
researcher. The anthropometric measurements will include the following: body weight, height, 
and body mass index (BMI). BMI will be calculated by the standard method (body weight [kg]/ 
height [m]2) from weight and height measurements. The vital signs assessed will be resting 
blood pressure, heart rate, and respiratory rate. Following anthropometric data collection and 
vital signs, the participants will be instructed on the use of the wearable sleep tracker and 
provided assistance with setting up and charging the device. Participants will be instructed to 
contact the PI with any questions throughout the study by email or phone. The participants will 
then watch the sleep hygiene education video created by the research team.  
Following the initial meeting with the PI, the participants will wear the sleep tracker on their wrist 
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, sleep midpoint, and time spent at each stage of sleep. Within the first week of 
participating in the study, student researcher(s) will contact the participant and perform a short 
5- minute qualitative interview on the participants understanding and comprehension of the 
educational video along with a satisfaction survey (using a 5-point Likert scale).  At the end of 

the 4-week study period, the PI and/or student researcher(s) will once again meet with each 
participant.  The participant will complete the following questionnaires once again: Sleep diary, 
Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Sleep Hygiene Index, Perceived 
Stress Scale, Numeric Pain Rating Scale, and Patient Specific Functional Scale. Acceptability 
will be again assessed using a satisfaction survey (5-point Likert scale) and qualitative 
interview. Anthropometric data collection and vital signs will be reassessed, and the sleep 
tracker will be returned to the PI.  Pre/post measurements will be compared and data analyses 
will be conducted using a 2x2 mixed factorial repeated measures ANOVA test. The PI will be 
assisted in the stats process by her mentor, Dr. Siengsukon along with her peer in the 
psychology department at her university. 
During the first year of this study, when in the treatment development phase, our primary 
outcomes for feasibility will be the following: recruitment (people enrolled from people 
contacted), retention and attrition (participants who complete the study and number who drop 
out), adherence (number of sessions attended and adherence to intervention protocol). 
Acceptability will be assessed using the satisfaction survey (5-point Likert scale) and qualitative 
interview. This information will be used to tailor the intervention to CDOA to further assess 
treatment effect in year two and three.  
Assessing overall sleep health is relatively new and therefore there is no established gold 
standard, however the Ru-SATED questionnaire (Table 1) has been shown to be a reliable and 
valid measure of sleep health.[35] We will use this in combination of objective data from the 
FitBit device to measure sleep health. Each sleep health domain will be dichotomized using the 
cut-off points in Table 1 with 0 = poor sleep health and 1 = good sleep health. The domains will 
be summed to create the composite sleep health score ranging from 0 - 6 with a higher score 
indicating better sleep health.  
Table 1 Sleep Health Composite  
Sleep health 
domain 
Source  
Operational definition 
Cut-off for 
good sleep 
health 
Regularity 
FitBit 
Standard deviation of sleep 
midpoint, which is calculated as 
[sleep onset + (wake time – sleep 
onset/2)] 
<60 min 
Satisfaction 
Sleep Diary 
The sleep diary includes an item to 
rate “restedness upon awakening” 
with 0 = “not at all”, 1 = “somewhat”, 
2= “moderately”, 3 = “quite a bit”, 
and 4 = “extremely”. Satisfaction will 
be operationalized as the average 
“restedness” score 
Average of 
≥3 
Alertness 
Epworth 
Sleepiness 
Scale 
Epworth Sleepiness Scale which 
consists of 8-items of various 
activities (ie. sitting and reading, 
watching TV, etc) answered using a 
4-point Likert Scale with 0 = “would 
never nod off” to 3 = “high chance of 
nodding off” 
≤10 
Timing 
FitBit 
Average sleep midpoint  
2am-4am 

Efficiency 
FitBit 
Average total minutes of sleep 
divided by time in bed multiplied by 
100 
>85% 
Duration 
FitBit 
Average total minutes of sleep  
6-8 hours 
Table 1: Sleep Health Composite  
 
 
 
 
 
 
 
Figure 1: Study design for Specific Aim 1. 
Specific Aim 2: Assess the ability of daily automated text messaging in CDOA to serve as 
an effective augmentation for sleep hygiene education.  
Rationale:  Our second aim is to study the effectiveness of sending automated text messaging 
as an effective augmentation for sleep hygiene education in CDOA. With the promising short 
term results of a one-time sleep hygiene education session in young adults and the working 
adult population, we want to test if reinforcing the education daily through the use of a simple 
text message over the course of 4 weeks provides even greater and more sustainable results 
on changing people’s sleep behaviors. The expansion of smartphone technology combined with 
the abundance of services offering bulk messages to be sent out automatically provides an 
opportunity to reinforce the initial education with continual reminders of good sleep habits that 
an individual can practice over the course of 4-weeks. Given that 86% of adults over 50 now 
consistently use text messaging; it is safe to say this is an easy way to provide daily education 
and reminders on good sleep habits to this population.[28] If a new habit can be solidified during 
this timeframe, perhaps we will see long-term changes in sleep that will greatly improve overall 
health and wellness. For these reasons, we want to explore using automated text messaging as 
a supplement to our 30-minute educational video for sleep hygiene education.  
Experimental design: Following anthropometric data collection and vital signs, as well as having 
the participants watch the sleep hygiene education video created by the research team, the 
participants will be randomly assigned to one of two groups (Figure 2). The intervention group 
will receive daily automated text messages scheduled for 8:00 pm every evening. The text 
messages will include a variety of sleep hygiene behavioral tips for the participant to try (Table 
2). 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 4 weeks, PI and student 
researcher(s) will meet again with the participants to collect the same data that was collected at 
the initial visit. Each participant will have a total of 2 sessions to complete with each session 
taking approximately 45-60 minutes to complete.   
 
Participants (n=80) 
Assessments  
Epworth Sleepiness Scale, Pittsburgh Sleep Quality 
Index, Sleep Hygiene Index, Perceived Stress Scale, 
Numeric Pain Rating Scale, and Patient Specific 
Functional Scale. 
Body Weight, 
Height, and 
Body Mass 
Index 
Resting Heart Rate, 
Blood Pressure, and 
Respiratory Rate  
Qualitative 
interview, 
satisfaction survey 
Participants (n=30) 

 
 
 
 
Figure 2: Study design for Specific Aim 2. 
 
Day 
Daily Text 
1 & 16 
Go to sleep and wake up at the same time every day. This will help set your natural biological clock. 
2 & 17 
Exposure to bright natural light when you first wake up is also helpful to set your natural biological clock. 
3 & 18 
Use your bed for only sleep and sexual activity to help train your brain that if you are in your bed, you 
should be sleeping. Do not eat, work, or watch TV in bed. Do these activities outside of the bedroom. 
4 & 19 
Leave bed if unable to fall asleep within 20 minutes and return when sleepy. If unable to leave the bed 
due to limited mobility or safety concerns, do something relaxing (ie, relaxation techniques) until sleepy 
and able to fall to sleep. 
5 & 20 
Develop a relaxing bedtime routine. This may include taking a warm bath, reading a book, meditation, or 
stretching. Avoid stimulating activities right before bedtime, including watching TV or discussing a 
stressful topic. 
6 & 21 
Avoid moderate to vigorous exercise at least 2-3 hours before bedtime. Exercising immediately before 
bedtime stimulates your body and brain, making it hard to fall asleep. There is evidence however that 
doing regular (preferably moderate to vigorous) exercise improves your sleep at night. Talk to your 
physical therapist about an appropriate exercise program.  
 
7 & 22 
Avoid caffeinated foods and drinks at least 4 hours before bedtime (includes most tea, coffee, chocolate, 
and soft drinks). Check the presence of caffeine in your drink or food by reading the label. Caffeine can 
cause difficulty falling asleep and increase the number of times you wake up during the night. 
8 & 23 
Refrain from drinking alcohol or smoking at least 3 to 4 hours before bedtime. Although people may think 
drinking alcohol causes relaxation before bedtime it can actually increase the number of times you wake 
up during the night and can cause you to wake up early. Nicotine in cigarettes acts as a stimulant that 
can cause difficulty falling asleep. 
9 & 24 
Do not take unprescribed or over-the-counter sleeping pills. 
10 & 25 
Avoid daytime napping so that you are tired at night and can fall asleep easily. If you feel you need to 
take a nap, limit the nap to 30 minutes and avoid napping in the evening. 
11 & 26 
Make your sleeping environment comfortable and relaxing. This includes avoiding too much light and 
disturbing noises. Stop using light emitting electronics (ie, television, computer, smartphone) at least 30 
minutes before bedtime as the blue light that is emitted can disrupt sleep by suppressing melatonin 
production. Use ear plugs, light-blocking curtains, or an eye mask if needed. 
12 & 27 
Keep the temperature comfortable. Being too warm or cold may disturb your sleep. Also, use a 
comfortable and supportive pillow and mattress. 
13 & 28 
Avoid eating a large meal or spicy food 2-3 hours before going to bed. Your digestive system slows down 
while you are sleeping, which can stimulate acid secretions that cause heartburn. A light snack may be 
helpful if you are hungry. Avoid excessive liquid 2-3 hours before bedtime. 
14 & 29 
Eat nutritious, well balanced meals. Avoid eating a large amount of highly processed and sugary foods as 
these can disrupt the hormones that help regulate your sleep patterns. Instead try to make a habit of 
eating whole foods whenever possible. 
15 & 30 
Talk to your doctor or health professional if you still have trouble sleeping. 
Table 2: Sleep hygiene tips that will be sent out through text messaging 
 
Sleep Hygiene Education Video Plus Daily 
Automated Text Messaging Group 
(n=15)  
Sleep Hygiene Education Video Group 
(n=15)