The Efficacy of the Nanit-Insights App in Improving Infant Sleep

NCT03640533 | Terminated

• 1 other identifier: Insights
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.

Conditions

Infant Sleep Problems

Outcome Measures

Primary Outcomes (2)

• Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire

  Change from baseline in parent-reported sleep quality at 3 and 6 months follow-up using the Extended Brief Infant Sleep Questionnaire. Items in this questionnaire are either open-ended or reported on a 5-point scale, with 1=poor sleep quality and 5=very good sleep quality.

  Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.

• Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography

  Change from baseline in videosomnography metric of sleep efficacy at 3 and 6 months follow-up. infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. Sleep efficacy will be provided using the algorithm.

  Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups.

Secondary Outcomes (7)

• Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups.

  Parent sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.

• Change from baseline in parent mood as assessed using the Clinically Useful Depression Outcome Scale at 3 and 6 month follow ups.

  Parent mood will be assessed at baseline, and at 3- and 6-month follow-ups.

• Change from baseline in infant sleep onset latency at 3 and 6 months follow-up: Videosomnography

  Infant sleep onset latency will be assessed at baseline, and at 3- and 6-month follow-ups.

• Change from baseline in infant sleep duration at 3 and 6 months follow-up: Videosomnography

  Infant sleep duration will be assessed at baseline, and at 3- and 6-month follow-ups.

• Change from baseline in infant number of night-wakings at 3 and 6 months follow-up: Videosomnography

  Infant number of night-wakings will be assessed at baseline, and at 3- and 6-month follow-ups.

Study Arms (2)

Nanit-Insights intervention group

EXPERIMENTAL

Nanit-Insights is an app-based intervention that provides parents with personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.

Behavioral: Nanit-Insights

Nanit-monitor control group

NO INTERVENTION

Participants in the control group will be given the same monitoring device, that will serve in this group as a baby-monitor only, without providing sleep recommendations to parents.

Interventions

Nanit-Insights BEHAVIORAL

Nanit-Insights is an app-based intervention that provides personalized sleep tips to parents.

Nanit-Insights intervention group

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant aged 5-7 months
• Presence of a moderate to severe sleep problem at baseline
• Sleeping arrangement in which the infant sleeps in a crib at night

Sponsors & Collaborators

• Tel Aviv University: lead
• Flinders University: collaborator
• UdiSense Inc.: collaborator

Study Sites (1)

Nanit

New York, New York, 10018, United States

Location

Study Officials

• Michal Kahn, PhD

  Tel Aviv University

  STUDY DIRECTOR

• Michael Gradisar, PhD

  Flinders University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral fellow, Children's Sleep Laboratory

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: September 6, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)