Ramelteon for Insomnia Comorbid With Asthma

Phase 3

Terminated

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

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
1: Ramelteon	Ramelteon	-
2: Placebo	Ramelteon	-

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	baseline and post-treatment (at end of 5 weeks)	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
Insomnia Severity Index	5 weeks	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

Secondary Outcome Measures

Name	Time	Method
Daytime Sleepiness (Epworth Sleepiness Scale)	baseline and post-treatment (at end of 5 weeks)	Score of 0-24, with 24 being the most sleepy
Daytime Performance (Digit Symbol Substitution Test)	baseline and post-treatment (at end of 5 weeks)	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.
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min	baseline and during treatment period (during 5th week)