Ramelteon for Insomnia Comorbid With Asthma
Condition: Insomnia; Asthma
MeSH terms: Asthma; Sleep Initiation and Maintenance Disorders
Intervention: Ramelteon
Intervention description: melatonin agonist
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

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

Eligibility 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.