NCT03224455

Brief Summary

In this research study, investigators want to learn more about the factors that influence children's breathing during sleep and their sleep quality. Specifically, investigators are interested in factors that are related to risk of snoring, sleep apnea (a condition where breathing stops during sleep), and poor sleep quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2023

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

July 17, 2017

Last Update Submit

November 22, 2024

Conditions

Sleep Disorders in ChildrenEnvironmental Exposure

Keywords

sleepsleep in childrenchildren and sleepenvironmentenvironment and sleepenvironment and children

Outcome Measures

Primary Outcomes (2)

  • Apnea Hypopnea Index (AHI)

    Oxygen Desaturation Index (ODI; \>3%desaturation dips) registered in the WatchPAT. Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.

    2 days

  • Apnea Hypopnea Index (AHI)

    Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.

    7days

Secondary Outcomes (3)

  • sleep duration and sleep efficiency

    7 days

  • Sleepiness Quality of Life

    7 days

  • Quality of Life score

    7 days

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 6-12 years old who live in the Boston area.

You may qualify if:

  • Age 6-12 years
  • Children living (50% of the time or more) at their current residence for at least 1 month

You may not qualify if:

  • Children with severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
  • Children with severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
  • Children living in the current residence for \< 1 month will be not be eligible.
  • Families who do not speak English or Spanish well enough to complete the neuropsychological measures, as validated versions in other languages are not available for all of the measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Wanda Phipatanakul, MS. MS.

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

January 18, 2018

Primary Completion

June 30, 2022

Study Completion

June 17, 2023

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)