Testing and Development of a Sleep Training Mobile Health Application

Sleep Clinical Trial

Official title:

Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02718196
• Other study ID #: 1603017350
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: January 2021

Study information

• Verified date: November 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep training smartphone application using a sample of parents looking for sleep training advice online. 1a) To assess the efficacy of the application in helping parents with the sleep training process 1b) To assess the 'workability' of the application 2) Use feedback to guide the next round of development with the goal of building out the applications functionality and increasing usability.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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).

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Training smartphone application
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)	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
Primary	Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)	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
Primary	Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)	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
Primary	Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)	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