Ramelteon for Insomnia Comorbid With Asthma

Date de début de l'étude : 1 mars 2008

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.