Sleep Initiation and Maintenance DisordersSleepazoidNCT04550507
Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents
A study testing Mindful sensory awareness intervention and Mindful sensory awareness + mindful body awareness check-ins intervention in people with Sleep Initiation and Maintenance Disorders, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Eliminating media use is neither feasible at a public health level nor perhaps even desirable given the role it plays in the lives of youth and adults, but mind-body interventions have the potential to mitigate state arousal effects and thus reduce negative impacts on sleep. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Mindful sensory awareness intervention and Mindful sensory awareness + mindful body awareness check-ins intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age at enrollment is 11y0m to 14y11m
- Child is in the 6th-8th grade, or during summer recruitment, will be so in the coming autumn.
- Total score of 52 or higher on the Sleep Disturbances Scale for Children (SDSC), a parent-report survey questionnaire regarding child sleep health
- Parent reports child has >= 1 hour of media use during the 3 hours before bed at least 4 nights per week.
- Parent and child both are comfortable reading and hearing instructions in English and in answering surveys written in English.
- Families must also have at least two internet-connected portable screen devices available - one which much be an iOS or Android tablet or smartphone device and which will be used to download the games used in the media-induced arousal task and then used to play those games with the device in airplane mode, and a second which will be used to connect to the study staff via video conference, and which can be a laptop computer, tablet, or smartphone.
Who cannot join
- Untreated diagnosis (by parent report) or positive screen for sleep-disordered breathing on the SDSC parent report survey questionnaire
- Current use of medications known to affect sleep (systemic corticosteroids, stimulants, melatonin) by parent report
- Sleeps at a second residence from enrolling parent more than two nights a week according to parent report
- Has a current serious chronic medical condition known to affect sleep and/or arousal patterns (such as cancer or diabetes) by parent report.
- Currently engages in meditation or body scan to fall asleep, according to parent report
- We exclude potential participants who meet one of the following criteria because of concerns that their heart rate variability response may be too atypical to be valuable in this protocol (ASD or developmental delay, eating disorder, PTSD, illicit drug use) and/or because of concerns that the associated behavioral challenges and/or instability would impair ability to adhere to the entire 4-6 month protocol.
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- Diagnosis of Autism Spectrum Disorder or developmental delay by parent self-report
- Current diagnosis of eating disorder by parent self-report
- Current diagnosis of PTSD by parent self-report
- Illicit drug use within the last three months by parent self-report
- Is currently suicidal, based on the ASQ (Ask Suicide Screening Questions)
- Hospitalization for depression or anxiety in the last year by parent self-report; or severe current depression symptoms as indicated by a t-score > 80 on the RCADS-25. We will also exclude those with last year hospitalization, regardless of symptom score, because this is often an indicator of instability and undertreatment, and ability to adhere to the entire 4-6 month protocol would likely be impaired.
Trial locations and contacts
1 site in 1 country.
Michelle M Garrison, PhD contact
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98121
Clinical Research Coordinator, 206-884-1422, Sleepazoid@seattlechildrens.org
Michelle M Garrison, PhD, michelle.garrison@seattlechildrens.org
About this study
Official title: Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)
Eliminating media use is neither feasible at a public health level nor perhaps even desirable given the role it plays in the lives of youth and adults, but mind-body interventions have the potential to mitigate state arousal effects and thus reduce negative impacts on sleep. Given emerging literature on links between intensive media use, sensory and interoceptive awareness, and self-regulation, this study will examine two related mind-body approaches -- a mindfulness sensory awareness exercises and mindful body awareness check-ins -- in a randomized clinical trial of early adolescents with evening media use and sleep problems.
- Being tested
- Mindful sensory awareness intervention, Mindful sensory awareness + mindful body awareness check-ins intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful sensory awareness interventionBehavioural
The mindfulness sensory awareness exercise will be a brief (3-5 minutes), guided meditation focusing on sensory and interoceptive awareness developed by Co-I Price, modified slightly to meet the needs of this age group and targeted for attention to indicators of fatigue or a sense of overstimulation. Youth will be asked to use the exercise after ending media use but before trying to sleep. The meditation component will be delivered via an audio-guided MP3, along with illustrated instructions in both handout and video, and a guided workbook that coaches youth over the 8-week intervention period to practice their skills, reflect on their experiences, and maintain adherence.
Mindful sensory awareness + mindful body awareness check-ins interventionBehavioural
During the intervention period for Group B: Mindful Sensory \& Body Awareness(the second 8 weeks), they will receive the same mindful sensory awareness intervention, and also learn the mindful body awareness check-ins to guide media use choices strategy (referred to here as the check-ins component). We will coach youth to pause briefly every 30 minutes during media use to discern if they detect physical, cognitive, or emotional signs of escalated state arousal, and to make an intentional and real-time choice about possible changes in media use content or duration to help decrease state arousal levels before bed.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mindful Sensory Awareness | Experimental | Group A: Mindful Sensory Awareness receives the mindful sensory awareness intervention during the first 8-week period, and receives no active intervention delivery during the second 8-week period. Receives: Behavioral: Mindful sensory awareness intervention |
| Group B: Mindful Sensory and Body Awareness | Other | Group B: Mindful Sensory and Body Awareness receives no active intervention delivery during the first 8-week period, and during the second 8-week period receives an intervention combining the mindful sensory awareness content received by Group A with the mindful body awareness check-in approach. Receives: Behavioral: Mindful sensory awareness + mindful body awareness check-ins intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).
HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at 30 minutes prior to usual bedtime.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), beginning at usual bedtime
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).
HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at usual bedtime.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).
HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning when the youth reported on the diary starting to try to fall asleep.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), during game play exposure
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).
HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the game play exposure.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), during recovery period
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).
HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the recovery period post-exposure.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Secondary outcomes (7)
state arousal measured by electrodermal activity (EDA)
The Empatica E4 wrist-worn wireless telemetry device also measures electrodermal activity (EDA) in µSiemens, sampled at 4Hz. EDA will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods per measurement night at each of the following time periods, both in the home measurement weeks: a) beginning at 30 minutes prior to usual bedtime, b) beginning at usual bedtime, and c) beginning when the youth reported starting to try to fall asleep, with (b) and (c) being further apart on nights with greater behavioral bedtime delay, and in the remote assessments: d) in the last 5 minutes of the game play exposure, and e) in the last 5 minutes of the recovery period post-exposure.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits
The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep. Youth will complete this at the end of the post-exposure recovery period during each remote assessment visit. Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks
The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep. Youth will complete this each night during all home measurement weeks as part of the sleep diary, and the mean result across the week will be used. Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep onset latency (SOL)
time from diary-reported "going to bed" time to diary-reported time of sleep onset, averaged across one week
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep duration
diary-reported time of sleep onset to diary-reported time of sleep offset, averaged across one week
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Adolescent Sleep Wake Scale (ASWS) total sleep scale score
The ASWS (Adolescent Sleep Wake Scale) is a symptom scale of behavioral sleep problems common across pre-adolescence and adolescence, chosen because it does not focus on school days (and so appropriate year-round) and is written at Flesch-Kincaid Grade 4.5. Possible scores range from 5-30, with higher scores indicating better sleep.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
time to reach baseline arousal (HRV and EDA)
We will also evaluate the time to reach baseline state arousal levels (via HRV and EDA) after ceasing evening media use will be decreased in the intervention compared to the control group, in both remote assessment visit and home measurement week settings.
Measured: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start22 Oct 2020
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Washington
- Responsible party
- Principal investigator, Michelle Garrison, Seattle Children's Hospital
- Investigators
- Michelle M Garrison, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550507
- Sponsor's protocol ID
- STUDY00001443
- Other IDs
- R61AT009859
- Acronym
- Sleepazoid
- Status last verified
- Oct 2020
- First submitted
- 28 Aug 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)
- ClinicalTrials.gov ID
- NCT04550507
- Acronym / sponsor ID
- Sleepazoid / STUDY00001443
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Washington
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eliminating media use is neither feasible at a public health level nor perhaps even desirable given the role it plays in the lives of youth and adults, but mind-body interventions have the potential to mitigate state arousal effects and thus reduce negative impacts on sleep. Given emerging literature on links between intensive media use, sensory and interoceptive awareness, and self-regulation, this study will examine two related mind-body approaches -- a mindfulness sensory awareness exercises and mindful body awareness check-ins -- in a randomized clinical trial of early adolescents with evening media use and sleep problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Mindful Sensory Awareness | Experimental | Behavioral: Mindful sensory awareness interventionGroup A: Mindful Sensory Awareness receives the mindful sensory awareness intervention during the first 8-week period, and receives no active intervention delivery during the second 8-week period. |
| Group B: Mindful Sensory and Body Awareness | Other | Behavioral: Mindful sensory awareness + mindful body awareness check-ins interventionGroup B: Mindful Sensory and Body Awareness receives no active intervention delivery during the first 8-week period, and during the second 8-week period receives an intervention combining the mindful sensory awareness content received by Group A with the mindful body awareness check-in approach. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child age at enrollment is 11y0m to 14y11m
- Child is in the 6th-8th grade, or during summer recruitment, will be so in the coming autumn.
- Total score of 52 or higher on the Sleep Disturbances Scale for Children (SDSC), a parent-report survey questionnaire regarding child sleep health
- Parent reports child has >= 1 hour of media use during the 3 hours before bed at least 4 nights per week.
- Parent and child both are comfortable reading and hearing instructions in English and in answering surveys written in English.
Key exclusion criteria (12 listed)
- Untreated diagnosis (by parent report) or positive screen for sleep-disordered breathing on the SDSC parent report survey questionnaire
- Current use of medications known to affect sleep (systemic corticosteroids, stimulants, melatonin) by parent report
- Sleeps at a second residence from enrolling parent more than two nights a week according to parent report
- Has a current serious chronic medical condition known to affect sleep and/or arousal patterns (such as cancer or diabetes) by parent report.
- Currently engages in meditation or body scan to fall asleep, according to parent report
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 |
|---|---|---|
| Mindful sensory awareness interventionThe mindfulness sensory awareness exercise will be a brief (3-5 minutes), guided meditation focusing on sensory and interoceptive awareness developed by Co-I Price, modified slightly to meet the needs of this age group and targeted for attention to indicators of fatigue or a sense of overstimulation. Youth will be asked to use the exercise after ending media use but before trying to sleep. The meditation component will be delivered via an audio-guided MP3, along with illustrated instructions in both handout and video, and a guided workbook that coaches youth over the 8-week intervention period to practice their skills, reflect on their experiences, and maintain adherence. | Behavioural | Group A: Mindful Sensory Awareness |
| Mindful sensory awareness + mindful body awareness check-ins interventionDuring the intervention period for Group B: Mindful Sensory \& Body Awareness(the second 8 weeks), they will receive the same mindful sensory awareness intervention, and also learn the mindful body awareness check-ins to guide media use choices strategy (referred to here as the check-ins component). We will coach youth to pause briefly every 30 minutes during media use to discern if they detect physical, cognitive, or emotional signs of escalated state arousal, and to make an intentional and real-time choice about possible changes in media use content or duration to help decrease state arousal levels before bed. | Behavioural | Group B: Mindful Sensory and Body Awareness |
Primary outcome
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at 30 minutes prior to usual bedtime.
state arousal measured by heart rate variability (HRV), beginning at usual bedtime
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at usual bedtime.
state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning when the youth reported on the diary starting to try to fall asleep.
state arousal measured by heart rate variability (HRV), during game play exposure
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the game play exposure.
state arousal measured by heart rate variability (HRV), during recovery period
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the recovery period post-exposure.
7 secondary outcomes
state arousal measured by electrodermal activity (EDA)
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep onset latency (SOL)
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep duration
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Adolescent Sleep Wake Scale (ASWS) total sleep scale score
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
time to reach baseline arousal (HRV and EDA)
Time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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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.
Michelle M Garrison, PhD contact
Michelle M Garrison, PhD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful sensory awareness intervention and Mindful sensory awareness + mindful body awareness check-ins intervention in people with Sleep Initiation and Maintenance Disorders, run by Seattle Children's Hospital 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator ((206) 884-1422, Sleepazoid@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime (time frame: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).). The study lists 5 primary outcomes in all. 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 26 Oct 2020.