Ramelteon for Insomnia Comorbid With Asthma

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

Study Overview

• Status: Terminated
• Conditions: Insomnia; Asthma
• Intervention / Treatment: Drug: Ramelteon

Detailed Description

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Ramelteon	Drug: Ramelteon; melatonin agonist; Other Names: Rozerem
Placebo Comparator: 2: Placebo	Drug: Ramelteon; melatonin agonist; Other Names: Rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms	baseline and post-treatment (at end of 5 weeks)
Insomnia Severity Index	The change in ISI and PSQI from baseline to end of study will be compared between the two groups. PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Sleepiness (Epworth Sleepiness Scale)	Score of 0-24, with 24 being the most sleepy	baseline and post-treatment (at end of 5 weeks)
Daytime Performance (Digit Symbol Substitution Test)	DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters. DSST score can range from 0-125, with 125 being the most number correct during the allotted time period.	baseline and post-treatment (at end of 5 weeks)
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min		baseline and during treatment period (during 5th week)

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Takeda
• Investigators: Principal Investigator: Brandon S Lu, MD, MS, Northwestern University

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Sleep Initiation and Maintenance Disorders; Asthma
• Other Study ID Numbers: 07-052R