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| Name | Class |
|---|---|
| Airweave Pte Ltd. | INDUSTRY |
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The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms.
The study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low rebound mattress toppers | Experimental | sleep with mattress topper during overnight diagnostic sleep study |
|
| High rebound mattress toppers | Experimental | sleep with mattress topper during overnight diagnostic sleep study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low rebound mattress toppers | Device | Patients will sleep on this mattress topper during their diagnostic sleep study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | Overnight study visit (up to approximately 10hrs) | |
| Sleep Efficiency Assessed by Polysomnography (PSG) | 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. | Overnight study visit (up to approximately 10hrs) |
| Sleep Latency Assessed by PSG | The amount of time from lights off to falling asleep. | Overnight study visit (up to approximately 10hrs) |
| Wake After Sleep Onset (WASO) Assessed by PSG | Total amount of minutes awake after the first sleep epoch. | Overnight study visit (up to approximately 10hrs) |
| Percentage of Time in Bed During Each Sleep Stage | Overnight study visit (up to approximately 10hrs) | |
| Position Changes Assessed by PSG | Number of times participant changed position during the sleep recording. | Overnight study visit (up to approximately 10hrs) |
| Apnea Hypopnea Index Assessed by PSG | The number of apneas or hypopneas recorded during the study per hour of sleep. | Overnight study visit (up to approximately 10hrs) |
| Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Core Body Temperature | 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. | Overnight study visit (up to approximately 10hrs) |
| Visual Analog Scale of Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seiji Nishino, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Sleep Research Center | Stanford | California | 94305 | United States |
4 participants were enrolled but not randomized to a study arm.
Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Rebound Mattress Toppers | Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic. |
| BG001 | High Rebound Mattress Toppers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was collected through online form, and not all participants entered age information. |
| 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 | Total Sleep Time | 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. | Posted | Mean | Standard Deviation | hours | Overnight study visit (up to approximately 10hrs) |
|
Study visit overnight (up to 24hrs)
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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 | Low Rebound Mattress Toppers | Participants in arm 1 slept on low rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Seiji Nishino | Stanford University | 650-725-8602 | nishino@stanford.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 | Aug 4, 2015 | Oct 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2020 | Oct 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| High rebound mattress toppers | Device | Patients will sleep on this mattress topper during their diagnostic sleep study. |
|
|
| Overnight study visit (up to approximately 10hrs) |
| Periodic Leg Movements (PLM) During Sleep | Number of times participant had periodic leg movements during the sleep recording | Overnight study visit (up to approximately 10hrs) |
| Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | EEG data collected from the electrode in position C2 | Overnight study visit (up to approximately 10hrs) |
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). |
| Overnight study visit (up to approximately 10hrs) |
| Visual Analog Scale of Performance | 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). | Overnight study visit (up to approximately 10hrs) |
| Visual Analog Scale of Mood | visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good). | Overnight study visit (up to approximately 10hrs) |
| Alliance Sleep Questionnaire (ASQ) | self-reported information related to sleep | Overnight study visit (up to approximately 10hrs) |
Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Room temperature | Room temperature was not recorded for all participants. | Mean | Standard Deviation | degrees Celsius |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Sleep Efficiency Assessed by Polysomnography (PSG) | 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. | 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. | Posted | Mean | Standard Deviation | percentage time in bed asleep | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Sleep Latency Assessed by PSG | The amount of time from lights off to falling asleep. | 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. | Posted | Mean | Standard Deviation | minutes | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Wake After Sleep Onset (WASO) Assessed by PSG | Total amount of minutes awake after the first sleep epoch. | 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. | Posted | Mean | Standard Deviation | minutes | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Percentage of Time in Bed During Each Sleep Stage | 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. | Posted | Mean | Standard Deviation | percentage of time in bed | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Position Changes Assessed by PSG | Number of times participant changed position during the sleep recording. | 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. | Posted | Mean | Standard Deviation | number of position changes | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Apnea Hypopnea Index Assessed by PSG | The number of apneas or hypopneas recorded during the study per hour of sleep. | 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. | Posted | Mean | Standard Deviation | number of events per hour | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Heart Rate | 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. | Posted | Mean | Standard Deviation | Beats per minute | Overnight study visit (up to approximately 10hrs) |
|
|
|
| Primary | Periodic Leg Movements (PLM) During Sleep | Number of times participant had periodic leg movements during the sleep recording | 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. | Posted | Mean | Standard Deviation | number of PLM events | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Primary | Mean EEG Delta Spectral Power Per Second Over 90 Mins From Lights Off Between 0-360 Minutes After Lights Off | EEG data collected from the electrode in position C2 | 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. | Posted | Mean | Standard Deviation | µV^2 | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Secondary | Core Body Temperature | 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. | 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. | Posted | Mean | Standard Deviation | degrees Celsius | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Secondary | Visual Analog Scale of Sleep | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Secondary | Visual Analog Scale of Performance | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Secondary | Visual Analog Scale of Mood | visual analog scale of mood was used for evaluation of subjective mood. Scale ranged from 0 cm (very bad) to 10 cm (very good). | 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. | Posted | Mean | Standard Deviation | units on a scale | Overnight study visit (up to approximately 10hrs) |
|
|
|
|
| Secondary | Alliance Sleep Questionnaire (ASQ) | self-reported information related to sleep | Data were not collected for this outcome measure. | Posted | Overnight study visit (up to approximately 10hrs) |
|
|
| 0 |
| 281 |
| 0 |
| 281 |
| 0 |
| 281 |
| EG001 | High Rebound Mattress Toppers | Participants in arm 2 slept on high rebound mattress toppers placed on top of standard mattresses equipped at the Stanford Sleep Clinic. | 0 | 273 | 0 | 273 | 0 | 273 |
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| D001523 | Mental Disorders |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| Non REM stage 1 |
|
| Non REM stage 2 |
|
| Non REM stage 3 |
|
| 0.06 |
| Other |
| Analysis of Non REM stage 1 values | t-test, 2 sided | 0.83 | Other |
| Analysis of Non REM stage 2 values | t-test, 2 sided | 0.87 | Other |
| Analysis of Non REM stage 3 values | t-test, 2 sided | 0.97 | Other |
| 90-180min |
|
|
| 180-270min |
|
|
| 270-360min |
|
|
| 0.29 |
| Other |
| analysis of 180-270 minutes | t-test, 2 sided | 0.58 | Other |
| analysis of 270-360 min | t-test, 2 sided | 0.62 | Other |
| 90min since lights off |
|
| 120min since lights off |
|
| 150min since lights off |
|
| 180min since lights off |
|
| 210min since lights off |
|
| 240min since lights off |
|
| 270min since lights off |
|
| 300min since lights off |
|
| 330min since lights off |
|
| 360min since lights off |
|
Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.
| ANOVA |
| 0.01 |
| Other |
| Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT. | ANOVA | 0.642 | Other |