Adolescent BehaviorNCT03843762
Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
An observational study of Adolescent Behavior, run by Duke University at 1 site in United States.
Trial summary
The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 16 Mar 2020
- Phase
- Observational
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents will be recruited from primary and specialty health clinics.
Who may be able to join
- Male or Female
- Between the ages of 11 years 0 months to 17 years 11 months (inclusive), at the time of parental informed consent.
- Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
- Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.
Who cannot join
- Participants who have a diagnosis of occult sleep disorders (i.e., sleep apnea, periodic leg movement syndrome)
- Participants who currently use prescribed or over-the-counter sleep aids (i.e., melatonin)
- Participants who have acute or chronic medical illnesses or medications that may interfere with sleep as determined by the research team.
- Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.
Read the detailed description
This project will involve recruitment of 100 adolescents from primary and specialty health clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and follow-up visit.
The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit, participants and their parents will complete questionnaires regarding the adolescent's psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood pressure) will also be assessed and recorded.
Eligible participants will enter the 7-day sleep study, during which they will be asked to wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a daily sleep diary.
Following the final night of the sleep study, participants and parents will be asked to return for a follow-up visit and will complete questionnaires about the participants' sleep over the past week.
- Conditions
- Adolescent Behavior
- Keywords
- Adolescents, Sleep, Actigraphy, Psychiatric Health
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Adolescents, male or female, ages 11 - 17. Participants will complete 7 days/nights of actigraphy and sleep-based EEG and questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood
"Internalizing symptoms" and "Externalizing symptoms" subscales of the Child Behavior Checklist (CBCL)
Measured: 1 Day
Secondary outcomes (1)
Acceptability of Devices - Tolerability Scale
Tolerability will be assessed using the At Home PSG Tolerability Scale, developed by Dr. Lunsford-Avery (PI) and colleagues. This scale measures comfort of devices while asleep and awake, sleep disturbances resulting from device use, and satisfaction with the devices.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start6 May 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica R Lunsford-Avery, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843762
- Sponsor's protocol ID
- Pro00101670
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lunsford-Avery JR, Keller C, Kollins SH, Krystal AD, Jackson L, Engelhard MM. Feasibility and Acceptability of Wearable Sleep Electroencephalogram Device Use in Adolescents: Observational Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e20590. doi: 10.2196/20590.
PubMed 33001035
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
- ClinicalTrials.gov ID
- NCT03843762
- Acronym / sponsor ID
- Pro00101670
- Conditions
- Adolescent Behavior
- Keywords
- Adolescents, Sleep, Actigraphy, Psychiatric Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 18 Feb 2019 (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 overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.
Detailed description
This project will involve recruitment of 100 adolescents from primary and specialty health clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and follow-up visit.
The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit, participants and their parents will complete questionnaires regarding the adolescent's psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood pressure) will also be assessed and recorded.
Eligible participants will enter the 7-day sleep study, during which they will be asked to wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a daily sleep diary.
Following the final night of the sleep study, participants and parents will be asked to return for a follow-up visit and will complete questionnaires about the participants' sleep over the past week.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –Adolescents, male or female, ages 11 - 17. Participants will complete 7 days/nights of actigraphy and sleep-based EEG and questionnaires. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents will be recruited from primary and specialty health clinics.
Key inclusion criteria (4 listed)
- Male or Female
- Between the ages of 11 years 0 months to 17 years 11 months (inclusive), at the time of parental informed consent.
- Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
- Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.
Key exclusion criteria (4 listed)
- Participants who have a diagnosis of occult sleep disorders (i.e., sleep apnea, periodic leg movement syndrome)
- Participants who currently use prescribed or over-the-counter sleep aids (i.e., melatonin)
- Participants who have acute or chronic medical illnesses or medications that may interfere with sleep as determined by the research team.
- Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood
Time frame: 1 Day
"Internalizing symptoms" and "Externalizing symptoms" subscales of the Child Behavior Checklist (CBCL)
1 secondary outcome
Acceptability of Devices - Tolerability Scale
Time frame: 1 day
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 27 Apr 2020.
- Derived from this study: PubMed 33001035Lunsford-Avery JR, Keller C, Kollins SH, Krystal AD, Jackson L, Engelhard MM. Feasibility and Acceptability of Wearable Sleep Electroencephalogram Device Use in Adolescents: Observational Study. JMIR Mhealth Uhealth. 2020 Oct 1;8(10):e20590. doi: 10.2196/20590.
- 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.
Jessica R Lunsford-Avery, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior, run by Duke 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 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 27 Apr 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?
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?
Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843762, which also lists 1 linked publication.
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 27 Apr 2020.