Trial Outcomes & Findings for Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms (NCT NCT03055156)
NCT ID: NCT03055156
Last Updated: 2020-11-06
Results Overview
COMPLETED
NA
558 participants
Overnight study visit (up to approximately 10hrs)
2020-11-06
Participant Flow
Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.
4 participants were enrolled but not randomized to a study arm.
Participant milestones
| Measure |
Low Rebound Mattress Toppers
Participants in arm 1 slept on low rebound mattress toppers (Topper Deluxe 3.5, TEMPUR-SEALY Japan Ltd., Kobe, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
Participants in arm 2 slept on high rebound mattress toppers (airweave® toppers, airweave inc., Tokyo, Japan) placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
273
|
|
Overall Study
COMPLETED
|
281
|
273
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was collected through online form, and not all participants entered age information.
Baseline characteristics by cohort
| Measure |
Low Rebound Mattress Toppers
n=281 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=273 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
Total
n=554 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
39.42 years
STANDARD_DEVIATION 15.84 • n=200 Participants • Age was collected through online form, and not all participants entered age information.
|
41.27 years
STANDARD_DEVIATION 15.93 • n=175 Participants • Age was collected through online form, and not all participants entered age information.
|
40.28 years
STANDARD_DEVIATION 15.89 • n=375 Participants • Age was collected through online form, and not all participants entered age information.
|
|
Sex: Female, Male
Female
|
129 Participants
n=281 Participants
|
135 Participants
n=273 Participants
|
264 Participants
n=554 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=281 Participants
|
138 Participants
n=273 Participants
|
290 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Asian
|
44 Participants
n=281 Participants
|
42 Participants
n=273 Participants
|
86 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 Participants
n=281 Participants
|
14 Participants
n=273 Participants
|
22 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
18 Participants
n=281 Participants
|
26 Participants
n=273 Participants
|
44 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=281 Participants
|
2 Participants
n=273 Participants
|
3 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=281 Participants
|
0 Participants
n=273 Participants
|
2 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
186 Participants
n=281 Participants
|
173 Participants
n=273 Participants
|
359 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
7 Participants
n=281 Participants
|
4 Participants
n=273 Participants
|
11 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=281 Participants
|
0 Participants
n=273 Participants
|
1 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=281 Participants
|
12 Participants
n=273 Participants
|
19 Participants
n=554 Participants
|
|
Race/Ethnicity, Customized
Participant indicated Multiple and Other
|
7 Participants
n=281 Participants
|
2 Participants
n=273 Participants
|
9 Participants
n=554 Participants
|
|
Region of Enrollment
United States
|
281 Participants
n=281 Participants
|
273 Participants
n=273 Participants
|
554 Participants
n=554 Participants
|
|
Body Mass Index
|
26.22 kg/m^2
STANDARD_DEVIATION 5.61 • n=281 Participants
|
26.34 kg/m^2
STANDARD_DEVIATION 5.41 • n=273 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 5.51 • n=554 Participants
|
|
Room temperature
|
20.84 degrees Celsius
STANDARD_DEVIATION 1.41 • n=215 Participants • Room temperature was not recorded for all participants.
|
20.88 degrees Celsius
STANDARD_DEVIATION 1.42 • n=215 Participants • Room temperature was not recorded for all participants.
|
20.84 degrees Celsius
STANDARD_DEVIATION 1.41 • n=430 Participants • Room temperature was not recorded for all participants.
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=216 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=200 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Total Sleep Time
|
6.62 hours
Standard Deviation 1.25
|
6.55 hours
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Sleep efficiency is total sleep time divided by time in bed. All data were collected through the PSG data that were retrieved from the patients' medical records after completion of the recordings and analysis by the sleep technologists.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=216 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=200 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Sleep Efficiency Assessed by Polysomnography (PSG)
|
82.87 percentage time in bed asleep
Standard Deviation 11.34
|
79.73 percentage time in bed asleep
Standard Deviation 14.94
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
The amount of time from lights off to falling asleep.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=214 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=199 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
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|---|---|---|
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Sleep Latency Assessed by PSG
|
18.67 minutes
Standard Deviation 21.00
|
24.05 minutes
Standard Deviation 25.31
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Total amount of minutes awake after the first sleep epoch.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=215 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=199 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
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Wake After Sleep Onset (WASO) Assessed by PSG
|
60.09 minutes
Standard Deviation 43.57
|
74.36 minutes
Standard Deviation 67.55
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=214 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=198 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
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Percentage of Time in Bed During Each Sleep Stage
Non REM stage 3
|
11.86 percentage of time in bed
Standard Deviation 10.58
|
11.81 percentage of time in bed
Standard Deviation 16.09
|
|
Percentage of Time in Bed During Each Sleep Stage
Wake
|
17.11 percentage of time in bed
Standard Deviation 11.38
|
20.16 percentage of time in bed
Standard Deviation 14.92
|
|
Percentage of Time in Bed During Each Sleep Stage
REM
|
16.26 percentage of time in bed
Standard Deviation 6.96
|
14.92 percentage of time in bed
Standard Deviation 7.52
|
|
Percentage of Time in Bed During Each Sleep Stage
Non REM stage 1
|
6.36 percentage of time in bed
Standard Deviation 4.83
|
6.46 percentage of time in bed
Standard Deviation 4.58
|
|
Percentage of Time in Bed During Each Sleep Stage
Non REM stage 2
|
47.67 percentage of time in bed
Standard Deviation 12.22
|
47.36 percentage of time in bed
Standard Deviation 12.69
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Number of times participant changed position during the sleep recording.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=213 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=197 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
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|---|---|---|
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Position Changes Assessed by PSG
|
14.64 number of position changes
Standard Deviation 12.76
|
15.65 number of position changes
Standard Deviation 10.45
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
The number of apneas or hypopneas recorded during the study per hour of sleep.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=213 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=198 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Apnea Hypopnea Index Assessed by PSG
|
34.15 number of events per hour
Standard Deviation 57.00
|
33.86 number of events per hour
Standard Deviation 45.48
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=216 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=200 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Heart Rate
|
61.24 Beats per minute
Standard Deviation 14.19
|
64.82 Beats per minute
Standard Deviation 10.48
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Number of times participant had periodic leg movements during the sleep recording
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=203 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=181 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
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|---|---|---|
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Periodic Leg Movements (PLM) During Sleep
|
99.56 number of PLM events
Standard Deviation 143.43
|
91.51 number of PLM events
Standard Deviation 11.36
|
PRIMARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
EEG data collected from the electrode in position C2
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=210 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=196 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
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Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
0-90min
|
31.34 µV^2
Standard Deviation 30.71
|
31.93 µV^2
Standard Deviation 36.61
|
|
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
90-180min
|
28.61 µV^2
Standard Deviation 31.56
|
32.00 µV^2
Standard Deviation 32.61
|
|
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
180-270min
|
24.19 µV^2
Standard Deviation 31.55
|
27.02 µV^2
Standard Deviation 67.62
|
|
Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off
270-360min
|
21.66 µV^2
Standard Deviation 38.68
|
20.07 µV^2
Standard Deviation 23.35
|
SECONDARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
Difference in core body temperature changes of the high and low rebound mattress toppers at sleep onset and during sleep. The core body temperature will be monitored every minute throughout the night.
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=145 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=142 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
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Core Body Temperature
30min since lights off
|
36.42 degrees Celsius
Standard Deviation 1.15
|
36.29 degrees Celsius
Standard Deviation 1.23
|
|
Core Body Temperature
60min since lights off
|
36.49 degrees Celsius
Standard Deviation 0.34
|
36.52 degrees Celsius
Standard Deviation 0.34
|
|
Core Body Temperature
90min since lights off
|
36.46 degrees Celsius
Standard Deviation 0.34
|
36.49 degrees Celsius
Standard Deviation 0.35
|
|
Core Body Temperature
120min since lights off
|
36.47 degrees Celsius
Standard Deviation 0.33
|
36.51 degrees Celsius
Standard Deviation 0.34
|
|
Core Body Temperature
150min since lights off
|
36.51 degrees Celsius
Standard Deviation 0.33
|
36.53 degrees Celsius
Standard Deviation 0.32
|
|
Core Body Temperature
180min since lights off
|
36.54 degrees Celsius
Standard Deviation 0.32
|
36.56 degrees Celsius
Standard Deviation 0.31
|
|
Core Body Temperature
210min since lights off
|
36.56 degrees Celsius
Standard Deviation 0.33
|
36.57 degrees Celsius
Standard Deviation 0.30
|
|
Core Body Temperature
240min since lights off
|
36.59 degrees Celsius
Standard Deviation 0.31
|
36.61 degrees Celsius
Standard Deviation 0.32
|
|
Core Body Temperature
270min since lights off
|
36.58 degrees Celsius
Standard Deviation 0.36
|
36.64 degrees Celsius
Standard Deviation 0.38
|
|
Core Body Temperature
300min since lights off
|
36.59 degrees Celsius
Standard Deviation 0.33
|
36.65 degrees Celsius
Standard Deviation 0.30
|
|
Core Body Temperature
330min since lights off
|
36.61 degrees Celsius
Standard Deviation 0.28
|
36.64 degrees Celsius
Standard Deviation 0.29
|
|
Core Body Temperature
360min since lights off
|
36.62 degrees Celsius
Standard Deviation 0.28
|
36.63 degrees Celsius
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
visual analog scale of sleep was used for evaluation of subjective sleep quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=194 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=170 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Visual Analog Scale of Sleep
|
4.93 units on a scale
Standard Deviation 2.33
|
4.80 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
visual analog scale of performance was used for evaluation of subjective performance quality. Scale ranged from 0 cm (very bad) to 10 cm (very good).
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=192 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=167 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Visual Analog Scale of Performance
|
5.54 units on a scale
Standard Deviation 2.21
|
5.45 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Participants with non missing data, who completed the study during the night, and did not initiate CPAP or biPAP during the study were included in the analysis.
visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good).
Outcome measures
| Measure |
Low Rebound Mattress Toppers
n=192 Participants
Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
High Rebound Mattress Toppers
n=169 Participants
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
|
|---|---|---|
|
Visual Analog Scale of Mood
|
6.60 units on a scale
Standard Deviation 2.06
|
6.60 units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Overnight study visit (up to approximately 10hrs)Population: Data were not collected for this outcome measure.
self-reported information related to sleep
Outcome measures
Outcome data not reported
Adverse Events
Low Rebound Mattress Toppers
High Rebound Mattress Toppers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place