Clinical trial NCT00869167: Ramelteon for Insomnia Comorbid With Asthma
Official title: Ramelteon for Insomnia Comorbid With Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Insomnia
Asthma
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2009-03-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline and post-treatment (at end of 5 weeks)
measure: Insomnia Severity Index
timeFrame: 5 weeks
Secondary outcomes:
measure: Daytime Sleepiness (Epworth Sleepiness Scale)
timeFrame: baseline and post-treatment (at end of 5 weeks)
measure: Daytime Performance (Digit Symbol Substitution Test)
timeFrame: baseline and post-treatment (at end of 5 weeks)
measure: Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
timeFrame: baseline and during treatment period (during 5th week)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Brandon S Lu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: