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Completed

NCT Number: NCT03073187

Sleep Quality in High School Students With Asthma

The overall goal of this project is to develop and to preliminarily validate a novel intervention to be delivered in the high school setting that integrates two evidence-based, school-based interventions for urban adolescents with proven efficacy: (1) Asthma Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and behaviors in urban adolescents.

The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews.

The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period.

This record is for Phase I only.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University, New York, United States

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About this study

Sleep quality among adolescents is poor and asthma's impact is significant among adolescents. Asthma control is an important risk factor for poor sleep and poor academic performance. In addition, poor asthma control, poor sleep hygiene, and poor sleep quality are more likely in urban settings. Interventions to promote sleep quality by targeting both asthma control and sleep hygiene in this vulnerable population are lacking.

To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).

Who can participate

Healthy volunteers accepted: Yes

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

ADOLESCENT-CAREGIVER DYADS (20 adolescents with persistent asthma and poor sleep, and their caregivers - 10 in Step 1 and 10 in Step 3)

Inclusion criteria

  • a prior asthma diagnosis in the prior 12 months;
  • use of prescribed asthma medications;
  • persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
  • sleep duration < 8 hours

Exclusion criteria

  • report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
  • A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
  • active immunotherapy;
  • additional pulmonary disease; and
  • significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.

SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)

Inclusion criteria

  • Teach at the high school level.

Exclusion criteria

  • Unwilling to participate in the study.

Treatment and study plan

Primary outcomes

  1. Number of subjects successfully completing the interview

    Time frame: Up to 10 months

    Subjects will be interviewed regarding their preference and opinions about adapted curriculum.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Mar 5, 2021

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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