- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02718196
Testing and Development of a Sleep Training Mobile Health Application
Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Problems with bedtime and night-wakings are common in early childhood. Behavioral interventions to address these sleep problems are commonly referred to as "sleep training" and are effective but difficult for some parents to perform. The investigators have developed a prototype of a novel smartphone application designed to assist parents throughout this process.
The smartphone application first collects basic information from the parents, including: first name of child, number of caregivers participating in bedtime, tolerance of caregivers for crying, and basic information about timing of sleep and wake, as well as information about the usual order of events at bedtime. At each step, a brief (2-3 paragraph) is provided to explain the rationale for the next step, as well as concrete advice on how to succeed. It then walks parents through proven techniques to improve sleep in children in a stepwise fashion.
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- english speaking
- parent of child age 6-24 months
- target child sleeping in crib in his or her own room (not the same room as the parents or a sibling)
- actively looking to sleep train their child
- own an iOS or Android smartphone
Exclusion Criteria:
- bedsharing/cosleeping with child
- target child has a known developmental delay
- target child has a significant health issue affecting his/her sleep (failure to thrive, congenital heart disease, etc).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Application Users
English-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.
|
Every evening the application provides a list of the planned bedtime activities as well as the recommended bedtime.
The steps are 1) positive bedtime routine 2) bedtime fading 3)addressing nocturnal feeding 4) extinction protocol
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)
Tidsramme: study entry and 1 month
|
The question is: Average number of night wakings per night: ____________ Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. |
study entry and 1 month
|
Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)
Tidsramme: study entry and 3 months
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.
The question is: Average number of night wakings per night: ____________
|
study entry and 3 months
|
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)
Tidsramme: study entry
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep as a problem? □ A very serious problem □ A small problem □ Not a problem at all |
study entry
|
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)
Tidsramme: 3 months
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.
The question is: Do you consider your child's sleep as a problem?
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1603017350
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Søvn
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University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
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Aventure ABAktiv, ikke rekrutterende
-
National Taiwan University HospitalUkendt
-
National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
-
Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
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University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
-
Tyco Healthcare GroupUkendt
-
Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland