Circadian DysrhythmiaNCT03217708
Post Discharge Circadian Rhythms Post Adenotonsillectomy
An observational study of Circadian Dysrhythmia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Circadian Dysrhythmia
- What is being tested?
- Jawbone UP4
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 17 Mar 2022
- How long will I take part?
- 3 Weeks
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: We are testing variability in circadian biomarkers
Who may be able to join
- As stated previously, OSA v. non OSA
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).
The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device.
Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).
Read the detailed description
Wearable technology has tremendous advantages over current methods of assessing RTB activity in the post-discharge pediatric population after AT, which rely on quality of life (QOL) scales, caregiver and patient reports, as well as nurse phone calls and office visits. These methods are biased, time and labor intensive, disease focused, and caregiver dependent. The investigators propose to use wearable technology in order to assess RTB activity. The device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). So far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. RTB is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. There are no studies or "standard" to measure quality of recovery in children.
- Conditions
- Circadian Dysrhythmia
- Being tested
- Jawbone UP4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jawbone UP4Device
Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Children without OSA | Children for AT due to chronic tonsillitis without OSA. Receives: Device: Jawbone UP4 | |
| Children with OSA | Children with OSA for AT as determined by PSG Receives: Device: Jawbone UP4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circadian rhythm
HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT
Measured: 3 week
Change in circadian rhythm
Sleep in OSA group v. non OSA group post AT. Specifically the design will capture sleep metrics (REM v. non REM, arousals, movement) in order to assess sleep quality.
Measured: 3 weeks
Change in activity
Activity change in OSA group v. non OSA group post AT. Due to the device being able to measure activity (specifically measured as step count as indicated in the introduction), these can be compared between groups.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start21 Aug 2017
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Why it stopped: Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian DysrhythmiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvind Chandrakantan, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217708
- Sponsor's protocol ID
- H-39906
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).
- ClinicalTrials.gov ID
- NCT03217708
- Acronym / sponsor ID
- H-39906
- Conditions
- Circadian Dysrhythmia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 14 Jul 2017 (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 utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device.
Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).
Detailed description
Wearable technology has tremendous advantages over current methods of assessing RTB activity in the post-discharge pediatric population after AT, which rely on quality of life (QOL) scales, caregiver and patient reports, as well as nurse phone calls and office visits. These methods are biased, time and labor intensive, disease focused, and caregiver dependent. The investigators propose to use wearable technology in order to assess RTB activity. The device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). So far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. RTB is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. There are no studies or "standard" to measure quality of recovery in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children without OSA | – | Device: Jawbone UP4Children for AT due to chronic tonsillitis without OSA. |
| Children with OSA | – | Device: Jawbone UP4Children with OSA for AT as determined by PSG |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We are testing variability in circadian biomarkers
Key inclusion criteria (1 listed)
- As stated previously, OSA v. non OSA
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Jawbone UP4Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery. | Device | Children with OSA, Children without OSA |
Primary outcome
Change in circadian rhythm
Time frame: 3 week
HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT
Change in circadian rhythm
Time frame: 3 weeks
Sleep in OSA group v. non OSA group post AT. Specifically the design will capture sleep metrics (REM v. non REM, arousals, movement) in order to assess sleep quality.
Change in activity
Time frame: 3 week
Activity change in OSA group v. non OSA group post AT. Due to the device being able to measure activity (specifically measured as step count as indicated in the introduction), these can be compared between groups.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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?
An observational study of Circadian Dysrhythmia, run by Baylor College of Medicine 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in circadian rhythm (time frame: 3 week). The study lists 3 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 31 Mar 2022.