SleepNCT06501690
Feasibility of a Bedtime Variability Protocol
A study testing Late bedtime and Variable bedtime in people with Sleep, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Late bedtime and Variable bedtime
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to 30 Sep 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 6-10 years
- Parent age 18 years or older
- Child has a regular bedtime (goes to bed within 30 minutes of the same time on 5 or more days per week)
Who cannot join
- Child has a medical condition impacting sleep (e.g., narcolepsy, sleep apnea)
- Child has a developmental disorder or delay (e.g., autism, Down syndrome)
- Child regularly takes supplements or medications (prescription or over the counter) for sleep, such as melatonin or antihistamines
- Not English speaking
- Not willing to follow bedtime protocol
- Residing in the same household as a current or previous participant (i.e., only 1 child per household may complete study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol.
Read the detailed description
The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. Children with medical conditions or taking medications affecting sleep, or children who do not have a regular bedtime, will be excluded. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol. Participants will attend an initial enrollment visit to complete consent and receive instruction on the protocol. Participants will then complete the three experimental conditions in a randomized, counterbalanced order. Participants will complete a phone or Zoom check in at the end of the first two conditions, and an in-person or Zoom visit at the end of the third condition where their opinions about the protocol feasibility and acceptability will be assessed, answer any questions, and provide them instruction for the next condition (when applicable).
- Conditions
- Sleep
- Being tested
- Late bedtime, Variable bedtime
- Keywords
- sleep, bedtime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late bedtimeBehavioural
Participants will go to bed 1 hour later than their habitual bedtime
Variable bedtimeBehavioural
Participants will go to bed at a prescribed time that varies each day within +/-1 hour of habitual bedtime
| Study group | Role | What they receive |
|---|---|---|
| Habitual bedtime | No intervention | For one week, children will follow their habitual bedtime. |
| Late bedtime | Experimental | For one week, children will go to bed one hour later than their habitual bedtime Receives: Behavioral: Late bedtime |
| Variable bedtime | Experimental | For one week, children will go to bed at a prescribed time that will vary each day within +/- 1 hour of habitual bedtime. Receives: Behavioral: Variable bedtime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to bedtime protocol
Parents will report on the time their child went to bed
Measured: Daily during each of the 3, one-week intervention periods
Secondary outcomes (2)
Parent perception of feasibility of following the protocol (semi-structured interview)
Parents will provide qualitative answers to questions about their perceptions of following the protocol, including but not limited to whether the protocol was easy to follow, disruptive to their life, disruptive to their child's life.
Measured: At the end of 3 week study
Sleep duration
Child sleep duration during each intervention period, measured by actigraphy
Measured: Daily during each of the 3, one-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start10 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete 3, one week long intervention periods in a randomized order
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Hohman, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501690
- Sponsor's protocol ID
- STUDY00025204
- Status last verified
- Nov 2024
- First submitted
- 2 Jul 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Bedtime Variability Protocol
- ClinicalTrials.gov ID
- NCT06501690
- Acronym / sponsor ID
- STUDY00025204
- Conditions
- Sleep
- Keywords
- sleep, bedtime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Jul 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 purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol.
Detailed description
The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. Children with medical conditions or taking medications affecting sleep, or children who do not have a regular bedtime, will be excluded. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol. Participants will attend an initial enrollment visit to complete consent and receive instruction on the protocol. Participants will then complete the three experimental conditions in a randomized, counterbalanced order. Participants will complete a phone or Zoom check in at the end of the first two conditions, and an in-person or Zoom visit at the end of the third condition where their opinions about the protocol feasibility and acceptability will be assessed, answer any questions, and provide them instruction for the next condition (when applicable).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will complete 3, one week long intervention periods in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Habitual bedtime | No intervention | –For one week, children will follow their habitual bedtime. |
| Late bedtime | Experimental | Behavioral: Late bedtimeFor one week, children will go to bed one hour later than their habitual bedtime |
| Variable bedtime | Experimental | Behavioral: Variable bedtimeFor one week, children will go to bed at a prescribed time that will vary each day within +/- 1 hour of habitual bedtime. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child age 6-10 years
- Parent age 18 years or older
- Child has a regular bedtime (goes to bed within 30 minutes of the same time on 5 or more days per week)
Key exclusion criteria (6 listed)
- Child has a medical condition impacting sleep (e.g., narcolepsy, sleep apnea)
- Child has a developmental disorder or delay (e.g., autism, Down syndrome)
- Child regularly takes supplements or medications (prescription or over the counter) for sleep, such as melatonin or antihistamines
- Not English speaking
- Not willing to follow bedtime protocol
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 |
|---|---|---|
| Late bedtimeParticipants will go to bed 1 hour later than their habitual bedtime | Behavioural | Late bedtime |
| Variable bedtimeParticipants will go to bed at a prescribed time that varies each day within +/-1 hour of habitual bedtime | Behavioural | Variable bedtime |
Primary outcome
Adherence to bedtime protocol
Time frame: Daily during each of the 3, one-week intervention periods
Parents will report on the time their child went to bed
2 secondary outcomes
Parent perception of feasibility of following the protocol (semi-structured interview)
Time frame: At the end of 3 week study
Sleep duration
Time frame: Daily during each of the 3, one-week intervention period
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 8 Nov 2024.
- 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.
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 Late bedtime and Variable bedtime in people with Sleep, run by Penn State University 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 3 inclusion and 6 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 8 Nov 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?
Adherence to bedtime protocol (time frame: Daily during each of the 3, one-week intervention periods). 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 8 Nov 2024.