Sleep, InadequateNCT06549868
Using Yoga to Reduce Chaos and Improve Preschooler Sleep
A study testing Yoga-based bedtime routine in people with Sleep, Inadequate and Sleep, run by Emily Guseman at 1 site in United States.
Trial summary
The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Inadequate, Sleep
- What is being tested?
- Yoga-based bedtime routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 13 May 2022
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children between 2.0-5.9 years of age and their self-identified primary parent/guardian
Who cannot join
- Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:
Will families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.
Participants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will \"cross over\" to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.
- Conditions
- Sleep, Inadequate, Sleep
- Being tested
- Yoga-based bedtime routine
- Keywords
- sleep, children, preschool, yoga, parents, household chaos
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-based bedtime routineBehavioural
Dyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book.
At week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Participants will be asked to follow a yoga-based bedtime routine for 4 weeks Receives: Behavioral: Yoga-based bedtime routine |
| Story | Other | Waitlist control arm. Participants will complete a 4-week control period upon randomization. After this control period is completed, they will crossover into the intervention group and follow the same 4 week intervention as the yoga group. Receives: Behavioral: Yoga-based bedtime routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention adherence
Number of yoga sessions completed Percent of prescribed sessions completed
Measured: 4 weeks
Household chaos
Measured using Chaos, Hubbub, and Order Scale (CHAOS) at enrollment, crossover point, and study completion. A lower CHAOS score post-intervention would indicate an improvement in household chaos.
Measured: at week 1, week 5, and week 10
Secondary outcomes (5)
Child sleep duration
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
Measured: at week 1, week 5, and week 10
Parent sleep duration
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
Measured: 1 week at week 1, week 5, and week 10
Parent sleep quality
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
Measured: 1 week at week 1, week 5, and week 10
Child sleep quality
nightly sleep measured by waist-worn accelerometer
Measured: 1 week at week 1, week 5, and week 10
Child sleep quality
measured by Children's Sleep Habits Questionnaire (CSHQ; scored using mean and standard deviation of survey items. A higher CSHQ mean score indicates worse sleep quality)
Measured: 1 week at week 1, week 5, and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Jul 2019
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep, InadequateStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily Guseman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emily Guseman, Ohio University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549868
- Sponsor's protocol ID
- 19-X-124
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study for a planned full-scale intervention
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Yoga to Reduce Chaos and Improve Preschooler Sleep
- ClinicalTrials.gov ID
- NCT06549868
- Acronym / sponsor ID
- 19-X-124
- Conditions
- Sleep, Inadequate, Sleep
- Keywords
- sleep, children, preschool, yoga, parents, household chaos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emily GusemanUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 12 Aug 2024 (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.
The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:
Will families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.
Participants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will \"cross over\" to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga-based bedtime routineParticipants will be asked to follow a yoga-based bedtime routine for 4 weeks |
| Story | Other | Behavioral: Yoga-based bedtime routineWaitlist control arm. Participants will complete a 4-week control period upon randomization. After this control period is completed, they will crossover into the intervention group and follow the same 4 week intervention as the yoga group. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children between 2.0-5.9 years of age and their self-identified primary parent/guardian
Key exclusion criteria (1 listed)
- Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine
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 |
|---|---|---|
| Yoga-based bedtime routineDyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book. At week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period. | Behavioural | Story, Yoga |
Primary outcome
Intervention adherence
Time frame: 4 weeks
Number of yoga sessions completed Percent of prescribed sessions completed
Household chaos
Time frame: at week 1, week 5, and week 10
Measured using Chaos, Hubbub, and Order Scale (CHAOS) at enrollment, crossover point, and study completion. A lower CHAOS score post-intervention would indicate an improvement in household chaos.
5 secondary outcomes
Child sleep duration
Time frame: at week 1, week 5, and week 10
Parent sleep duration
Time frame: 1 week at week 1, week 5, and week 10
Parent sleep quality
Time frame: 1 week at week 1, week 5, and week 10
Child sleep quality
Time frame: 1 week at week 1, week 5, and week 10
Child sleep quality
Time frame: 1 week at week 1, week 5, and week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Undecided. This is a pilot study for a planned full-scale intervention
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-based bedtime routine in people with Sleep, Inadequate and Sleep, run by Emily Guseman 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 1 inclusion and 1 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 12 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention adherence (time frame: 4 weeks). The study lists 2 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 12 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.