Sleep Quality in High School Students With Asthma - II



Status:Enrolling by invitation
Conditions:Asthma, Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:13 - 17
Updated:5/16/2018
Start Date:April 9, 2018
End Date:July 2019

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A Pilot Study to Improve Sleep Quality in Urban 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 II only.

Sleep quality among adolescents is poor and asthma's impact is significant among adolescents.
Asthma control is an important risk factor for poor sleep. 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. We developed a novel intervention -- Managing Asthma and
Sleep in Teenagers (MAST) -- and in this phase of the study will evaluate the intervention's
feasibility and acceptability and assess the preliminary evidence of intervention effects on
improving sleep quality in urban high school students in NYC and Providence, RI. This study
is a multi-site trial and collaboration between Columbia University Medical Center and Rhode
Island Hospital (RIH).

The investigators hypothesize that: (1) The intervention will be feasible and acceptable as
evidenced by adolescents' high rates of adherence to the treatment protocol, and their high
satisfaction ratings and positive responses to exit interviews; and (2) relative to controls,
over 2-months post-intervention adolescents randomized to the intervention will have
significant improvement on the following outcomes assessing sleep quality: (1) sleep
efficiency; (2) night awakenings; and (3) sleep duration. If hypotheses are supported, the
investigators will explore whether treatment effects on sleep quality outcomes are mediated
through changes in asthma self-management (e.g., confidence to care for asthma, steps taken
to prevent the onset of symptoms, taking controller medication), and changes in sleep hygiene
and behaviors (e.g., consistent bedtime and wake time, consistent sleep location, fewer sleep
distractions in child's bedroom, decreased caffeine use). The investigators will also compare
MAST to the evidence-based intervention -- Asthma Self-Management for Adolescents (ASMA) --
to explore if whether an asthma intervention integrated with sleep hygiene components
enhances sleep quality above and beyond a behavioral, guideline-based asthma intervention.

To test how well MAST works, a pilot randomized controlled trial (RCT) with 84 urban
adolescents (42 = NYC; 42 = RI) with persistent asthma and whose typical sleep duration is
at/below what is recommended for this age group. Students will be recruited from high schools
in New York City and in Greater Providence, RI, two areas of high asthma prevalence for urban
adolescents. Students within schools will be randomized to one of three study arms: (1) MAST
-- the new intervention consisting of both asthma and sleep hygiene components; (2) the
original ASMA program; and (3) an informational and referral control group. The investigators
will follow students for two months post-intervention and explore differences in feasibility,
acceptability, and preliminary intervention effects by site.

Following consent, students and their parents/caregivers will complete baseline interviews,
and will be randomized into one of the three study conditions. The investigators will deliver
the intervention to the students at their respective schools, and will interview students and
their parents/caregivers when the intervention ends and two months later. At each assessment,
to assess sleep objectively, students will be asked to wear actigraph watches (Model AW2;
Mini Mittler) for 2 weeks. During this two week period, they will also complete asthma and
sleep logs where they record on a daily basis if they had asthma symptoms, took asthma
medication, had asthma-related limitations, and information about their sleep; these logs are
completed in the morning and the evening and should take less than 5 minutes each time to
complete.

Inclusion Criteria: Students will have

- (a) a prior asthma diagnosis;

- (b) used a prescribed asthma medication in the last 12 months; and

- (c) uncontrolled asthma, defined as (i) daytime symptoms 3+ days a week, (ii) night
awakenings 3+ nights per month, (iii) 2+ ED visits or (iv) 1+ hospitalization for
asthma; and (c) sleep duration 8.5 hours or less (at/below the appropriate number of
hours of sleep for this age group through the following questions: What time do you:
a) usually fall asleep on weekdays, b) usually wakeup on weekdays?).

Exclusion Criteria:

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

- 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.
We found this trial at
2
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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