Ramelteon for Insomnia Comorbid With Asthma

This study has been terminated.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Brandon Lu, Northwestern University
ClinicalTrials.gov Identifier:
NCT00869167
First received: March 19, 2009
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Insomnia
Asthma
Drug: Ramelteon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ramelteon for Insomnia Comorbid With Asthma

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index [ Time Frame: baseline and post-treatment (at end of 5 weeks) ] [ Designated as safety issue: No ]

    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


  • Insomnia Severity Index [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Daytime Sleepiness (Epworth Sleepiness Scale) [ Time Frame: baseline and post-treatment (at end of 5 weeks) ] [ Designated as safety issue: No ]
    Score of 0-24, with 24 being the most sleepy

  • Daytime Performance (Digit Symbol Substitution Test) [ Time Frame: baseline and post-treatment (at end of 5 weeks) ] [ Designated as safety issue: No ]

    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.


  • Daytime Lung Function (Peak Flow Monitoring) in Liter/Min [ Time Frame: baseline and during treatment period (during 5th week) ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Ramelteon Drug: Ramelteon
melatonin agonist
Other Name: Rozerem
Placebo Comparator: 2: Placebo Drug: Ramelteon
melatonin agonist
Other Name: Rozerem

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869167

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Takeda
Investigators
Principal Investigator: Brandon S Lu, MD, MS Northwestern University
  More Information

No publications provided

Responsible Party: Brandon Lu, Physician, Northwestern University
ClinicalTrials.gov Identifier: NCT00869167     History of Changes
Other Study ID Numbers: 07-052R
Study First Received: March 19, 2009
Results First Received: June 28, 2011
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Sleep Initiation and Maintenance Disorders
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014