Post Discharge Circadian Rhythms Post Adenotonsillectomy
17. marts 2022 opdateret af: Arvind Chandrakantan, Baylor College of Medicine
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).
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- Texas Childrens Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
5 år til 10 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
We are testing variability in circadian biomarkers
Beskrivelse
Inclusion Criteria:
- As stated previously, OSA v. non OSA
Exclusion Criteria:
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Children without OSA
Children for AT due to chronic tonsillitis without OSA.
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Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
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Children with OSA
Children with OSA for AT as determined by PSG
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Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in circadian rhythm
Tidsramme: 3 week
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HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT
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3 week
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Change in circadian rhythm
Tidsramme: 3 weeks
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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.
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3 weeks
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Change in activity
Tidsramme: 3 week
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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.
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3 week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. august 2017
Primær færdiggørelse (Faktiske)
17. marts 2022
Studieafslutning (Faktiske)
17. marts 2022
Datoer for studieregistrering
Først indsendt
25. april 2017
Først indsendt, der opfyldte QC-kriterier
12. juli 2017
Først opslået (Faktiske)
14. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-39906
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
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