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OpenTrials
Completed

NCT Number: NCT03224455

Environmental Assessment of Sleep in Youth

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: 2 days

    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. Apnea Hypopnea Index (AHI)

    Time frame: 7days

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

Secondary outcomes

  1. sleep duration and sleep efficiency

    Time frame: 7 days

    average of the sleep sensor readings

  2. Sleepiness Quality of Life

    Time frame: 7 days

    total score of Epworth Sleepiness Scale(ESS)

  3. Quality of Life score

    Time frame: 7 days

    total score of Pediatric Quality of Life (PedsQL) (0-100) 100 is better outcome

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

Environmental Risk Factors for Pediatric Sleep Disordered Breathing

Acronym: EASY

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2017
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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