Ramelteon for Insomnia Comorbid With Asthma

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Takeda

Criteria

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.