Status:
TERMINATED
Ramelteon for Insomnia Comorbid With Asthma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Takeda
Conditions:
Insomnia
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00869167
Start Date
March 1 2008
End Date
June 1 2009
Last Update
May 1 2013
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611