Sleep Quality in High School Students With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073187
• Other study ID #: AAAQ9707 - I
• Secondary ID: 1R21HD086448-01A
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: March 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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:

1. a prior asthma diagnosis in the prior 12 months;

2. use of prescribed asthma medications;

3. 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

4. sleep duration < 8 hours

Exclusion Criteria:

1. report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;

2. A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;

3. active immunotherapy;

4. additional pulmonary disease; and

5. 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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Sleep

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (33)

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Clark NM, Brown R, Joseph CL, Anderson EW, Liu M, Valerio M, Gong M. Issues in identifying asthma and estimating prevalence in an urban school population. J Clin Epidemiol. 2002 Sep;55(9):870-81. — View Citation

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Koinis-Mitchell D, Kopel SJ, Boergers J, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Beltran AJ, Klein RB, LeBourgeois M. Good Sleep Health in Urban Children With Asthma: A Risk and Resilience Approach. J Pediatr Psychol. 2015 Oct;40(9):888-903. doi: 10.1093/jpepsy/jsv046. Epub 2015 May 18. — View Citation

Koinis-Mitchell D, Kopel SJ, Boergers J, Ramos K, LeBourgeois M, McQuaid EL, Esteban CA, Seifer R, Fritz GK, Klein R. Asthma, allergic rhinitis, and sleep problems in urban children. J Clin Sleep Med. 2015 Jan 15;11(2):101-10. doi: 10.5664/jcsm.4450. — View Citation

Koinis-Mitchell D, McQuaid EL, Kopel SJ, Esteban CA, Ortega AN, Seifer R, Garcia-Coll C, Klein R, Cespedes E, Canino G, Fritz GK. Cultural-related, contextual, and asthma-specific risks associated with asthma morbidity in urban children. J Clin Psychol Med Settings. 2010 Mar;17(1):38-48. doi: 10.1007/s10880-009-9178-3. — View Citation

Koinis-Mitchell D, McQuaid EL, Seifer R, Kopel SJ, Esteban C, Canino G, Garcia-Coll C, Klein R, Fritz GK. Multiple urban and asthma-related risks and their association with asthma morbidity in children. J Pediatr Psychol. 2007 Jun;32(5):582-95. Epub 2007 Jan 11. — View Citation

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Spilsbury JC, Storfer-Isser A, Drotar D, Rosen CL, Kirchner LH, Benham H, Redline S. Sleep behavior in an urban US sample of school-aged children. Arch Pediatr Adolesc Med. 2004 Oct;158(10):988-94. — View Citation

Spilsbury JC, Storfer-Isser A, Kirchner HL, Nelson L, Rosen CL, Drotar D, Redline S. Neighborhood disadvantage as a risk factor for pediatric obstructive sleep apnea. J Pediatr. 2006 Sep;149(3):342-7. — View Citation

Vignau J, Bailly D, Duhamel A, Vervaecke P, Beuscart R, Collinet C. Epidemiologic study of sleep quality and troubles in French secondary school adolescents. J Adolesc Health. 1997 Nov;21(5):343-50. — View Citation

Williams DR, Sternthal M, Wright RJ. Social determinants: taking the social context of asthma seriously. Pediatrics. 2009 Mar;123 Suppl 3:S174-84. doi: 10.1542/peds.2008-2233H. — View Citation

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Wolfson AR, Harkins E, Johnson M, Marco C. Effects of the Young Adolescent Sleep Smart Program on sleep hygiene practices, sleep health efficacy, and behavioral well-being. Sleep Health. 2015 Sep;1(3):197-204. doi: 10.1016/j.sleh.2015.07.002. Epub 2015 Aug 13. — View Citation

Wong ML, Lau EY, Wan JH, Cheung SF, Hui CH, Mok DS. The interplay between sleep and mood in predicting academic functioning, physical health and psychological health: a longitudinal study. J Psychosom Res. 2013 Apr;74(4):271-7. doi: 10.1016/j.jpsychores.2012.08.014. Epub 2012 Sep 25. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects successfully completing the interview	Subjects will be interviewed regarding their preference and opinions about adapted curriculum.	Up to 10 months