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Ramelteon for Insomnia Comorbid With Asthma

Primary Purpose

Insomnia, Asthma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1: Ramelteon

2: Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Daytime Sleepiness (Epworth Sleepiness Scale)
Score of 0-24, with 24 being the most sleepy
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.
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min

Full Information

First Posted
March 19, 2009
Last Updated
April 26, 2013
Sponsor
Northwestern University
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00869167
Brief Title
Ramelteon for Insomnia Comorbid With Asthma
Official Title
Ramelteon for Insomnia Comorbid With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Ramelteon
Arm Type
Experimental
Arm Title
2: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
melatonin agonist
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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
Time Frame
baseline and post-treatment (at end of 5 weeks)
Title
Insomnia Severity Index
Description
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
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Daytime Sleepiness (Epworth Sleepiness Scale)
Description
Score of 0-24, with 24 being the most sleepy
Time Frame
baseline and post-treatment (at end of 5 weeks)
Title
Daytime Performance (Digit Symbol Substitution Test)
Description
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.
Time Frame
baseline and post-treatment (at end of 5 weeks)
Title
Daytime Lung Function (Peak Flow Monitoring) in Liter/Min
Time Frame
baseline and during treatment period (during 5th week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon S Lu, MD, MS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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