This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.
Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
melatonin agonist
Northwestern University
Chicago, Illinois, United States
Pittsburgh Sleep Quality Index
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Time frame: baseline and post-treatment (at end of 5 weeks)
Insomnia Severity Index
The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms
Time frame: 5 weeks
Daytime Sleepiness (Epworth Sleepiness Scale)
Score of 0-24, with 24 being the most sleepy
Time frame: baseline and post-treatment (at end of 5 weeks)
Daytime Performance (Digit Symbol Substitution Test)
DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters. DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.
Time frame: baseline and post-treatment (at end of 5 weeks)
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
Time frame: baseline and during treatment period (during 5th week)
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