Ramelteon for Insomnia Comorbid With Asthma

Study Overview
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Brief Summary
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This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Detailed Description
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Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Official Title
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Ramelteon for Insomnia Comorbid With Asthma

Conditions
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Insomnia, Asthma

Intervention / Treatment
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* Drug: Ramelteon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 - 60 with both insomnia and asthma. Insomnia: a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality, the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months. Additional inclusion criteria include: a subjective TST <6.5 h and a subjective SL > 45 min per night; a mean LPS >20 min over 2 consecutive nights by polysomnography (neither night could have been <15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score > 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep. Asthma will be diagnosed based on suggestive clinical history and either airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less bronchodilator-responsive expiratory airflow limitation (if FEV1 < 70% of predicted value or < 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score < 1.5. Exclusion Criteria: Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI > 15), periodic leg movements (movement arousal index > 15), REM behavior disorder; or circadian sleep-wake disorders History of cognitive or other neurological disorders; History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse; Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician; Unstable or serious medical conditions; Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally); Shift work or other types of self imposed irregular sleep schedules; Obesity (BMI > 35 Kg/m2); or Pregnancy or desire to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Ramelteon<br> | Drug: Ramelteon<br>* melatonin agonist<br>* Other names: Rozerem;|
| Placebo Comparator: 2: Placebo<br> | Drug: Ramelteon<br>* melatonin agonist<br>* Other names: Rozerem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Sleepiness (Epworth Sleepiness Scale) | Score of 0-24, with 24 being the most sleepy | 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. | baseline and post-treatment (at end of 5 weeks) | 
| Daytime Lung Function (Peak Flow Monitoring) in Liter/Min |  | baseline and during treatment period (during 5th week) |