Autism Spectrum DisordersNCT02739321
Examining the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD
A study testing Sound to Sleep System in people with Autism Spectrum Disorders, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 30 months to 13 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Sound to Sleep System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASD Diagnosis
- 2.5-12.99 Years of Age
- Sleep Difficulty as indicated by significant sleep disturbance on the Child Sleep Habits Questionnaire
- If participant is using medication or attends therapy, it must be stable four (4) weeks prior to their study participation and throughout the 5-6 week study period.
Who cannot join
- Age less than 2.5 years or more than 12.99 years
- Individuals who may have medication or therapy changes 4 weeks prior to study start date or during the study period
- An participant diagnosed with epilepsy, Fragile X, Downs Syndrome, seizure disorder, Neurofibromatosis, or Tuberous Sclerosis
- Any child with a pacemaker or other electrical device
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Autism
Cleveland, Ohio, 44104
About this study
Official title: A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD). The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in individuals with ASD and sleep disturbance by providing mattress vibrations that accompany and sync with auditory stimulation. For the present study, the primary objectives are as follows:
- Study Aim 1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected children with sleep disturbances is well tolerated as defined by group drop-out proportion due to issues with the mattress technology.
Read more
The study will also explore the following objectives:
- Study Aim 2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep quality as measured by parent reported sleep quality in ASD-affected children with sleep disturbances. (Please note Study Aim 2 was changed from clinician-rated to parent-rated because we were not able to collect clinician-rated sleep quality information).
- Study Aim 3 - To determine the tolerability of the Sound To Sleep System™ as defined by study drop-out due to any reason and caregiver ratings of ease of mattress technology use.
- Study Aim 4 - To determine whether use of the mattress technology improves functioning as defined by secondary outcome measures.
Read the detailed description
The present study aims to evaluate the tolerability and efficacy of a new mattress technology in improving the sleep quality of children with Autism Spectrum Disorder (ASD). Clinical and population studies indicate that children with ASD exhibit elevated rates of sleep disturbance compared to their typically-developing peers and that 50% to 80% of children with ASD have sleep problems. Sleep disturbance can include bedtime resistance, sleep onset latency, nighttime awakenings, decreased total sleep time, early morning awakenings, and other measures of sleep quality. Sleep problems in children with ASD are associated with greater externalizing and internalizing behavior problems during the waking day, poorer adaptive functioning, and can cause significant parental stress. Previous studies have examined the effectiveness of behavioral treatments, environmental modifications, melatonin, and psychopharmacologic treatments in decreasing the rates of sleep disturbance. However, none of these approaches have identified treatments that are effective for all ASD-affected children with sleep difficulties. Given the high prevalence of sleep disturbance in this population, there is a great need to identify additional treatments that may improve sleep in children with ASD.
The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To Sleep System™ using a single blind (actigraphy scoring blinded), cross-over design. The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in individuals with ASD and sleep disturbance by providing mattress vibrations that accompany and sync with auditory stimulation. For the present study, the primary objectives are as follows:
Study Aim 1- To determine whether the use of the Sound To Sleep System™ in ASD-affected children with sleep disturbances is well tolerated as defined by group drop-out proportion due to issues with the mattress technology.
The study will also explore the following objectives:
Study Aim 2- To determine the efficacy of the Sound To Sleep System™ in improving parent-reported sleep quality in ASD-affected children with sleep disturbances.
Study Aim 3- To determine the tolerability of the Sound To Sleep System™ as defined by study drop-out due to any reason and caregiver ratings of ease of mattress technology use.
Study Aim 4- To determine whether use of the mattress technology improves functioning as defined by secondary outcome measures.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Sound to Sleep System
- Keywords
- Autism, ASD, Sleep, Mattress
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound to Sleep SystemDevice
Sound to Sleep System is a minimal risk device that is embedded in a mattress boxspring. The device syncs with an audio input and emits tactile vibrations in sync with the audio input.
| Study group | Role | What they receive |
|---|---|---|
| Mattress Technology On then Off | Experimental | Intervention: Sound to Sleep System will be turned on for the first two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration.
No intervention: The mattress technology will be turned off for the second two weeks of the study. During this time, there will be no intervention. Receives: Device: Sound to Sleep System |
| Mattress Technology Turned Off then On | Experimental | No intervention: For the first two weeks of the study, the mattress technology will not be turned off. There will be no intervention during this time.
Intervention: Sound to Sleep System will be turned on for the second two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration. Receives: Device: Sound to Sleep System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
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.
Measured: up to 6 weeks
Secondary outcomes (17)
Parent Reported Quality of Sleep Across Treatment Conditions
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"
Measured: Average daily score, across up to 2 weeks
Total Time Asleep Recorded by Actigraphy Watch
Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch
Measured: Average of daily measure, across up to 2 weeks
Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch
Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions
Measured: Average of daily measure, across up to 2 weeks
Total Time Awake During Night Recorded by Actigraphy Watch
Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions
Measured: Average of daily measure, across up to 2 weeks
Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.
Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.
Measured: Average of daily measure, across up to 2 weeks
Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)
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.
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)
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.
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Communication Problems as Measured by the CCC-2
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.
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Problems With Sleep Habits as Measured by the FISH
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).
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)
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).
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ
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.
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire
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.
Measured: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary
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
Measured: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary
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).
Measured: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary
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).
Measured: Average of daily measure, across up to 4 Weeks
Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary
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).
Measured: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary
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.
Measured: Average daily measure, across up to 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Kugona LLC
- Responsible party
- Principal investigator, Thomas W. Frazier, Ph.D, The Cleveland Clinic
- Investigators
- Thomas Frazier, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739321
- Sponsor's protocol ID
- 14-066
- Status last verified
- Oct 2017
- First submitted
- 21 Jul 2014
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-Over Study of the Efficacy of Mattress Technology in Improving the Sleep Quality of Children With ASD and Sleep Disturbances
- ClinicalTrials.gov ID
- NCT02739321
- Acronym / sponsor ID
- 14-066
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism, ASD, Sleep, Mattress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Kugona LLC
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD). The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in individuals with ASD and sleep disturbance by providing mattress vibrations that accompany and sync with auditory stimulation. For the present study, the primary objectives are as follows:
- Study Aim 1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected children with sleep disturbances is well tolerated as defined by group drop-out proportion due to issues with the mattress technology.
The study will also explore the following objectives:
- Study Aim 2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep quality as measured by parent reported sleep quality in ASD-affected children with sleep disturbances. (Please note Study Aim 2 was changed from clinician-rated to parent-rated because we were not able to collect clinician-rated sleep quality information).
- Study Aim 3 - To determine the tolerability of the Sound To Sleep System™ as defined by study drop-out due to any reason and caregiver ratings of ease of mattress technology use.
- Study Aim 4 - To determine whether use of the mattress technology improves functioning as defined by secondary outcome measures.
Detailed description
The present study aims to evaluate the tolerability and efficacy of a new mattress technology in improving the sleep quality of children with Autism Spectrum Disorder (ASD). Clinical and population studies indicate that children with ASD exhibit elevated rates of sleep disturbance compared to their typically-developing peers and that 50% to 80% of children with ASD have sleep problems. Sleep disturbance can include bedtime resistance, sleep onset latency, nighttime awakenings, decreased total sleep time, early morning awakenings, and other measures of sleep quality. Sleep problems in children with ASD are associated with greater externalizing and internalizing behavior problems during the waking day, poorer adaptive functioning, and can cause significant parental stress. Previous studies have examined the effectiveness of behavioral treatments, environmental modifications, melatonin, and psychopharmacologic treatments in decreasing the rates of sleep disturbance. However, none of these approaches have identified treatments that are effective for all ASD-affected children with sleep difficulties. Given the high prevalence of sleep disturbance in this population, there is a great need to identify additional treatments that may improve sleep in children with ASD.
The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To Sleep System™ using a single blind (actigraphy scoring blinded), cross-over design. The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in individuals with ASD and sleep disturbance by providing mattress vibrations that accompany and sync with auditory stimulation. For the present study, the primary objectives are as follows:
Study Aim 1- To determine whether the use of the Sound To Sleep System™ in ASD-affected children with sleep disturbances is well tolerated as defined by group drop-out proportion due to issues with the mattress technology.
The study will also explore the following objectives:
Study Aim 2- To determine the efficacy of the Sound To Sleep System™ in improving parent-reported sleep quality in ASD-affected children with sleep disturbances.
Study Aim 3- To determine the tolerability of the Sound To Sleep System™ as defined by study drop-out due to any reason and caregiver ratings of ease of mattress technology use.
Study Aim 4- To determine whether use of the mattress technology improves functioning as defined by secondary outcome measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mattress Technology On then Off | Experimental | Device: Sound to Sleep SystemIntervention: Sound to Sleep System will be turned on for the first two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration. No intervention: The mattress technology will be turned off for the second two weeks of the study. During this time, there will be no intervention. |
| Mattress Technology Turned Off then On | Experimental | Device: Sound to Sleep SystemNo intervention: For the first two weeks of the study, the mattress technology will not be turned off. There will be no intervention during this time. Intervention: Sound to Sleep System will be turned on for the second two weeks of the study allowing the participant sleeping atop the mattress to feel the vibrations synced to the audio input. Sound to sleep system will be turned on during this phase of the study. The sound to sleep system will sync an audio input with the vibrations of the mattress technology and allow the user to control the intensity of the vibration. |
Who may qualify
- Ages
- 30 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASD Diagnosis
- 2.5-12.99 Years of Age
- Sleep Difficulty as indicated by significant sleep disturbance on the Child Sleep Habits Questionnaire
- If participant is using medication or attends therapy, it must be stable four (4) weeks prior to their study participation and throughout the 5-6 week study period.
Key exclusion criteria (4 listed)
- Age less than 2.5 years or more than 12.99 years
- Individuals who may have medication or therapy changes 4 weeks prior to study start date or during the study period
- An participant diagnosed with epilepsy, Fragile X, Downs Syndrome, seizure disorder, Neurofibromatosis, or Tuberous Sclerosis
- Any child with a pacemaker or other electrical device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound to Sleep SystemSound to Sleep System is a minimal risk device that is embedded in a mattress boxspring. The device syncs with an audio input and emits tactile vibrations in sync with the audio input. | Device | Mattress Technology On then Off, Mattress Technology Turned Off then On |
Primary outcome
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology
Time frame: 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.
17 secondary outcomes
Parent Reported Quality of Sleep Across Treatment Conditions
Time frame: Average daily score, across up to 2 weeks
Total Time Asleep Recorded by Actigraphy Watch
Time frame: Average of daily measure, across up to 2 weeks
Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch
Time frame: Average of daily measure, across up to 2 weeks
Total Time Awake During Night Recorded by Actigraphy Watch
Time frame: Average of daily measure, across up to 2 weeks
Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.
Time frame: Average of daily measure, across up to 2 weeks
Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Communication Problems as Measured by the CCC-2
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Problems With Sleep Habits as Measured by the FISH
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire
Time frame: Baseline, 2 weeks, 4 weeks
Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary
Time frame: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary
Time frame: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary
Time frame: Average of daily measure, across up to 4 Weeks
Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary
Time frame: Average of daily measure, across up to 2 Weeks
Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary
Time frame: Average daily measure, across up to 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Frazier, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound to Sleep System in people with Autism Spectrum Disorders, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.