Environmental Assessment of Sleep in Youth

Completed

• Conditions: Environmental Exposure; Sleep Disorders in Children

• Registration Number: NCT03224455
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Investigators are doing a research study to gather information to help better understand why snoring and sleep problems are so common in the community, and how the home and neighborhood environment impacts sleep in children. Investigators want to know if factors such as the quality of air, household dust, environmental noise, and family routines impact sleep and other health and behavioral factors associated with sleep.

Investigators want to test how sleep is influenced by factors such as: the quality of air inside and outside the child's home (including measuring pollution, second hand smoke, and dust); temperature and humidity; family routines and interactions; and characteristics of the home. Investigators will ask participants to come in for a one time visit for undergoing procedures as well as answering questions regarding general health, asthma and sleep. 10% of the participating children will have a second home assessment and sleep monitoring procedures performed 6 months after the initial home assessment.

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2018-01-18
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	7days	Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.

Secondary Outcome Measures

Name	Time	Method
sleep duration and sleep efficiency	7 days	average of the sleep sensor readings
Sleepiness Quality of Life	7 days	total score of Epworth Sleepiness Scale(ESS)
Quality of Life score	7 days	total score of Pediatric Quality of Life (PedsQL) (0-100) 100 is better outcome

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States