Environmental Assessment of Sleep in Youth

NCT ID: NCT03224455

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2023-06-17

Brief Summary

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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

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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.

Conditions

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Sleep Disorders in Children Environmental Exposure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wanda Phipatanakul

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wanda Phipatanakul, MS. MS.

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00025433

Identifier Type: -

Identifier Source: org_study_id

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