Trial Outcomes & Findings for Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD (NCT NCT02739321)

NCT ID: NCT02739321

Last Updated: 2017-11-06

Results Overview

Compare percentage of drop-out, in this cohort, due to issues with the mattress technology (e.g. ease of use, inability to fall asleep) to a population expected drop-out rate of 30% using a one-sample proportion test.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: up to 6 weeks
• Results posted on: 2017-11-06

Participant Flow

Enrolled participants take part in a one-week lead in period during which time all participants sleep with the box spring foundation of the new mattress technology, but with the mattress technology turned off, and wear an actigraphy watch. Participants who are unable to tolerate the actigraphy watch or the box spring foundation are excluded.

Participant milestones

Measure	Mattress Technology On Then Off Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to Sleep System turned on: For the first two weeks of the study, the sound to sleep system will be turned on during this arm of the study. For the second two weeks of the study, the Sound to Sleep System will be turned off, there is no intervention.	Mattress Technology Turned Off Then On Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to Sleep System: For the first two weeks of the study, the Sound to Sleep System is turned off, there is no intervention. For the second two weeks of the study, the Sound to Sleep System is turned on.
Overall Study STARTED	23	22
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Mattress Technology On Then Off Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to Sleep System turned on: For the first two weeks of the study, the sound to sleep system will be turned on during this arm of the study. For the second two weeks of the study, the Sound to Sleep System will be turned off, there is no intervention.	Mattress Technology Turned Off Then On Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to Sleep System: For the first two weeks of the study, the Sound to Sleep System is turned off, there is no intervention. For the second two weeks of the study, the Sound to Sleep System is turned on.
Overall Study Lack of Efficacy	1	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD

Baseline characteristics by cohort

Measure	Mattress Technology On n=23 Participants Intervention: The first two weeks of the study the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. The second two weeks of the study, the mattress technology will be turned off, there will be no intervention. Sound to Sleep System turned on: The first two weeks of the study the sound to sleep system will be turned on during this arm of the study. The second two weeks of the study, the sound to sleep system will be turned off, there will be no intervention.	Mattress Technology Turned Off n=22 Participants Intervention: The first two weeks of the study there will be no intervention. The second two weeks of the study, the mattress technology will be turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to Sleep System: The first two weeks of the study the sound to sleep system will be turned off, there will be no intervention. The second two weeks of the study the sound to sleep system will be turn on.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	6.0 years STANDARD_DEVIATION 2.5 • n=5 Participants	6.2 years STANDARD_DEVIATION 2.8 • n=7 Participants	6.1 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 weeks

Compare percentage of drop-out, in this cohort, due to issues with the mattress technology (e.g. ease of use, inability to fall asleep) to a population expected drop-out rate of 30% using a one-sample proportion test.

Outcome measures

Measure	Mattress Technology On Then Off n=23 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=22 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Average daily score, across up to 2 weeks

Within subjects comparison of the average daily, parent reported sleep quality across on and off conditions using a Likert-type scale of 1-7 in which 1 is "extremely poor" and 7 is "exceptional"

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Parent Reported Quality of Sleep Across Treatment Conditions	4.9 units on a scale Interval 4.67 to 5.14	4.3 units on a scale Interval 4.05 to 4.54	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 weeks

Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Total Time Asleep Recorded by Actigraphy Watch	8.35 Hours Standard Error 0.22	7.99 Hours Standard Error 0.22	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 weeks

Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch	14.11 Minutes Standard Error 5.75	18.20 Minutes Standard Error 6	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 weeks

Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Total Time Awake During Night Recorded by Actigraphy Watch	17.85 Minutes Standard Error 0.92	18.79 Minutes Standard Error 0.93	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 weeks

Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.	78.27 percentage of time Standard Error 1.48	75.45 percentage of time Standard Error 1.38	—

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of average Social Responsiveness Scale -2 (SRS-2) T-scores in baseline, and on and off conditions.

SRS-2 T-score ranges from 30-90 (M = 50, SD = 10). Higher T-scores indicate a greater extent of social communication deficits.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)	76.40 T-score Standard Error 1.61	73.68 T-score Standard Error 1.72	74.77 T-score Standard Error 1.71

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the parent completed Aberrant Behavior Checklist (ABC) total raw score in the baseline, and on and off conditions.

The ABC measures the level of challenging behavior of individuals in and across 5 subdomains (Irritability, lethargy, stereotypy, hyperactivity, inappropriate speech) using a Likert-type scale of 0-3 in which 0 is "not at all a problem" and 3 is "the problem is severe in degree". The sum raw scores of these subdomains make up the total ABC raw score (range = 0-174) in which a higher score indicates more severe challenging behaviors.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)	56.9 units on a scale Standard Error 4.25	48.61 units on a scale Standard Error 4.96	55.37 units on a scale Standard Error 4.91

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the average Children's Communication Checklist (CCC-2) General Communication Composite standard scores across baseline, and on and off conditions.

CCC-2 is a parent questionnaire that assesses children's communication skills across 10 domains using a 4-point Likert type scale (0=less than once a week/never to 3=several times a day/always). The general communication composite standard score based on age norms was used to asses overall communication competency (M=100, SD=15). Lower general communication composite scores indicate a higher likelihood of significant communication problems.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Communication Problems as Measured by the CCC-2	48.31 Standard Score Standard Error 2.59	52.31 Standard Score Standard Error 2.79	50.79 Standard Score Standard Error 2.74

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the Family Inventory of Sleep Hygiene (FISH) average total raw scores across baseline, and on and off conditions.

The FISH is a parent-completed questionnaire that assesses sleep hygiene-related behaviors in children using a 5-point Likert scale (1=Never, 2=occasionally, 3=Sometimes, 4=Usually, 5=Always). Typically parents rate these behaviors with reference to the past month, but for the present study they were asked to rate for only the previous two weeks to correspond to each mattress condition. The total raw score was used to asses sleep hygiene (Range = 12-60, in which higher scores are indicative of better sleep hygiene-related behaviors).

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Problems With Sleep Habits as Measured by the FISH	46.82 units on a scale Standard Error 0.70	48.79 units on a scale Standard Error 0.89	47.15 units on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the Children's Sleep Habits Questionnaire CSHQ average total raw scores across baseline and on and off conditions.

The CSHQ is a parent-completed questionnaire that measures a variety of sleep-related problems using a 3-point Likert-scale (1=rarely/0 to 1 times per week, 2= sometimes/2-4 times per week, 3=usually/5-7 times per week). Ordinarily, parents rate these behaviors for the pas week but for the present study they were instructed to rate for the past two weeks to correspond to the mattress on and off conditions. The total raw scores were use to evaluate overall sleep difficulties (Range = 45-135, in which a higher score is indicative of more sleep problems).

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)	56.53 units on a scale Standard Error 1.11	49.13 units on a scale Standard Error 1.37	52.66 units on a scale Standard Error 1.35

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the Short Sensory Profile Questionnaire (SSPQ) average total raw scores across baseline and on and off conditions.

The SSPQ is a parent-completed questionnaire that measures behaviors related to sensory processing abnormalities. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. The total raw score was used to evaluate overall sensory abnormalities (Range=38-190). Lower scores indicate a higher probability of sensory processing abnormalities.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ	124.58 units on a scale Standard Error 3.14	129.43 units on a scale Standard Error 4.02	125.49 units on a scale Standard Error 3.98

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 4 weeks

Within subjects comparison of the Child and Family Quality of Life 2 (CFQL-2), quality of life average total raw scores across baseline and on and off conditions.

The CFQL-2 is a parent questionnaire that evaluation seven different aspects of child and family quality of life (child, family, caregiver, financial, partner relationship, external support, and coping quality of life). An adapted version was used that decreased the number of total items from 32 to 26 and added an additional item to each scale to specifically evaluate changes of the past two weeks in quality of life. Items use a 5-point Likert scale ranging from (1=strongly disagree/decreased substantially to 3=neutral/same to 5=strongly agree/improved substantially). The total raw score was used to evaluate overall quality of life for child and family (Range=26-130). A lower, overall score indicates a lower quality of life for the child and their family.

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off n=45 Participants Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire	79.95 units on a scale Standard Error 1.77	84.54 units on a scale Standard Error 2.19	79.87 units on a scale Standard Error 2.14

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 Weeks

Within subjects comparison of average challenging behavior/task compliance, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptional" in the mattress technology on and off conditions

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=45 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary	4.73 units on a scale Standard Error 0.12	4.35 units on a scale Standard Error 0.12	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 Weeks

Comparison of average tolerance of mattress technology, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", in the on condition compared to the median score of 4 (average toleration of mattress technology).

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary	5.61 units on a scale Standard Error 0.25	—	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 4 Weeks

Comparison of average tolerance of the actigraph watch, measured on a scale of 1-7 in which 1 is "Extremely Poor" and 7 is "Exceptional", across treatment conditions compared to median score of 4 (average toleration of actigraph watch).

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary	5.51 units on a scale Standard Error 0.13	—	—

SECONDARY outcome

Timeframe: Average of daily measure, across up to 2 Weeks

Comparison of ease of mattress technology use, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy" in mattress technology on condition to median score of 4 (average ease of use of mattress technology).

Outcome measures

Measure	Mattress Technology On Then Off n=45 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary	6.04 units on a scale Standard Error 0.15	—	—

SECONDARY outcome

Timeframe: Average daily measure, across up to 2 Weeks

Within subjects comparison of average difficulty for child to go to bed, measured on a scale of 1-7 in which 1 is "Extremely Difficult" and 7 is "Exceptionally Easy", in the mattress technology on and off conditions.

Outcome measures

Measure	Mattress Technology On Then Off n=23 Participants For the first two weeks of the study, the mattress technology is turned on For the second two weeks of the study, the mattress technology is turned off, there is no intervention. Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Then On n=22 Participants For the first two weeks of the study, the mattress technology is turned off, there is no intervention. For the second two weeks of the study, the mattress technology is turned on Intervention: The mattress technology is turned on allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input.	Mattress Technology Off Participants who slept with the mattress technology turned off in either the first or second two weeks of the study.
Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary	4.28 units on a scale Standard Error 0.14	4.79 units on a scale Standard Error 0.14	—

Adverse Events

Mattress Technology On

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mattress Technology Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Frazier

The Cleveland Clinic

Email: fraziet2@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place